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Global Product Manager (Medical Device)
Northern CA
Responsibilities:
Develops a global segment market plan, strategies, objectives
and cross-functional tactics that create value to the customer.
Utilize strategic product plan and market research data to understand
market situation and opportunities.
Thorough analysis of market conditions, trends, competitive analysis
and other marketing research, define target markets (current and
potential future), adoption strategy and forecasts future adoption
rates.
Responsible for revenue modeling and pro forma, annual operating
plan resource requirements to support positive net present value
(NPV) projects.
Define customer/partner qualifications through an understanding
of customer/partner motivation, value drivers, buying process,
decision makers (individuals or units), frequency, purchase vehicle
for the near term and future.
Work with other cross functional departments, Sales, Marketing
Operations, Product Marketing, Finance, Clinical, and other business
partners to deliver sustained positive growth.
Create, develop and sustain a high performing team through individual
and team development and performance management.
Through monthly contact with the sales organization to identify
issues, trends and opportunities.
Manage the implementation of the strategic and tactical plans
for specific markets, partnerships or opportunities within the
market.
With Sr. Marketing Management create annual business plan and
budgets within functional area and support functions.
Participate in/develop sales and customer training strategies
that support business plan.
Establish successful working relationships within the service,
sales, marketing, clinical marketing, communication and product
planning departments.
Other duties as assigned.
Requirements:
BS/BA degree in Marketing, Business or related discipline.
5-8 years in a high production B2B and B2C marketing environment
People management experience.
Problem analysis and resolution at a strategic and functional
level
Ability to clearly and persuasively present viewpoints
Strong interpersonal skills with an interactive communication
style
Detailed project management skills
Proven leadership experience inclusive of the selection, development
and performance management of others.
Prior launch experience
Excellent communication skills including presentation skills
Experience in developing and executing marketing plans
Demonstrated analytical skills in market segment and/or business
analysis.
Possess a strong commitment to company values.
Working Conditions
Positions reports to Vice President of Marketing
Leadership role with direct reports.
Work is reviewed for adequacy in meeting objectives
Travel up to 30% of time required.
Senior Product Manager (Medical Device)
Northern CA
Responsibilities:
Work closely with Chief Technology Officer and R&D team to
develop the customer requirements for the companys products and
to support the development of these products.
Determine the applicability of the companys technology to various
clinical applications.
Prioritize the potential clinical applications and develop product
roadmap for the company.
Define the business strategy for the companys efforts.
Develop business plans for the companys products, including product
positioning, pricing, reimbursement, distribution, training, and
forecasts.
Provide detailed feedback to the R&D team on the performance
of the companys technology in pre-clinical and clinical testing.
Serve as an expert and in-house resource on existing and emerging
procedures in key clinical areas.
Identify limitations in these procedures and opportunities for
the companys products.
Establish close working relationships with leading gastroenterologists
and surgeons worldwide to ensure that the companys products meet
customer needs.
Initiate, develop, implement, and evaluate marketing programs.
Coordinate as needed with outside agencies to develop these programs.
Conduct market research and monitor competitor activity.
Requirements:
Bachelors degree (engineering preferred). MBA preferred.
Five years of work experience, with at least 2-3 years of experience
in marketing early stage products in the medical device field.
Sales, business development, or clinical experience a plus.
Experience in fields of gastroenterology or general surgery a
plus.
Ability to take initiative and willingness to travel (30%+)
Channel Marketing Manager (Medical Device)
Northern CA
Responsibilities:
Develop a channel market plan, strategies, objectives and cross-functional
tactics that create value to the customer(s)
Utilize strategic product plan and market research data to understand
market situation and opportunities.
Thorough analysis of market conditions, channel trends, competitive
analysis and other marketing research.
Define customer/partner qualifications through an understanding
of customer/partner motivation, value drivers, buying process,
decision makers (individuals or units), frequency, purchase vehicle
for the near term and future.
Work with other cross functional departments, Sales, Marketing
Operations, Product Marketing, Finance, Clinical, and other business
partners to delivery sustained positive growth.
Through monthly contact with the sales organization to identify
issues, trends and opportunities.
Manage the implementation of the strategic and tactical plans
for specific channel and partnerships within the market.
Participate in/develop pre-sales strategies and tactics and post-sales
practice management and customer training strategies that support
business plan.
Requirements:
BS/BA degree in Marketing, Business or related discipline.
5-8 years in a high production B2B and B2C marketing environment
Problem analysis and resolution at a strategic and functional
level
Ability to clearly and persuasively present viewpoints
Strong interpersonal skills with an interactive communication
style
Detailed project management skills
Proven leadership experience inclusive of the selection, development
and performance management of others.
Prior launch experience
Excellent communication skills including presentation skills
Experience in developing and executing marketing plans
Demonstrated analytical skills in market analysis.
Possess a strong commitment to company values.
Senior Quality Assurance Engineer (Medical Device)
Northern CA
Responsibilities:
Oversee implementation of design control requirements.
Conduct internal audits and be ready and responsive to inspectors.
Oversee the development and implementation of standards, methods
and procedures for inspecting, testing and evaluating the performance
and reliability of products.
Establish and maintain QA standards based on internal and external
specifications.
Enforce corrective actions necessary to assure conformity to quality
specifications.
Assure finished products conform to government and company standards
satisfying the QSR, ISO, Canadian and other foreign requirements.
Interface with other departments to assimilate new technologies
and to facilitate liaison with Manufacturing.
Requirements:
An engineering degree or equivalent.
A minimum of 5 years experience within the Quality organization
in a medical device company.
Additional peripheral experience within Manufacturing, Engineering
or Product Development desired.
Proven mastery of all aspects of the quality process, including
standards, methods and procedures.
Solid organizational, analytical and problem solving skills.
Excellent interpersonal skills and ability to influence and negotiate.
Experience with quality systems for medical devices.
Experience with the QSR, Canadian and ISO 13485:2003 requirements.
Marketing Communications Specialist (Medical Device)
Northern CA
Responsibilities:
Creates and produces advertisements, brochures, and other literature
as required
Responsible for the editing and proofing of all distributed communication
Writes advertising copy, newsletter articles, press releases,
and other documents as required
Manage and update website in support of marketing and sales activities
Planning, coordinating, promoting and managing company-led product/service
web seminars
Handling sales lead management and customer literature fulfillment.
Manage programs to budgets and timelines.
Measure and report effectiveness of programs through lead ROI
reports and other analysis tools.
Direct consultants and/or agencies and provide guidance to help
them understand our goals and strategies
Contribute to the continuous improvement, effectiveness and efficiency
of individual programs and overall program mix by applying best
practices and learnings
Requirements:
Four-year college degree in marketing, journalism, public relations,
communications, advertising or a related field
Five years experience in marketing, corporate communications,
or with an advertising agency
Excellent personal communication skills, both written and verbal
Experience in writing, editing and development of print materials
and web content
Excellent organization skills with attention to detail
Strong proof-reading ability
Proficient in Microsoft Office applications including Word, Excel
and PowerPoint, and page layout/drawing programs including Illustrator,
In Design, Quark and PhotoShop. Familiar with Sales Logic or other
database applications and HTML a plus
Process Development Engineer (Medical Device)
Northern CA
Responsibilities:
Design, develop, implement and maintain manufacturing processes
for assigned lines of products (devices).
Responsible for manufacturing engineering/process engineering
function on new product development teams for developing, implementing,
and maintaining assembly, test, and packaging processes.
Ensures that time lines, cost and quality expectations are met.
Responsible for training techs and assemblers and supporting transfer
of product into manufacturing facilities.
Provide accurate tracking and reporting on this activity.
Provide continuous engineering support on assigned products to
maintain and improve margin, performance and quality.
Work with team leader to deliver acceptable documentation on product
(including but not limited to: Assembly and test fixtures, Routers,
MPI, Test methods, Drawings and Specs) in a timely manner.
Participate and Manage (as required) engineering builds, verification
and validation builds, and provide technical data/ report to the
team leader.
Act as a team leader on projects assigned by the Manager of Process
Development.
Ensure compliance with quality system and all relevant internal
procedures and policies (including but not limited to: ECN, NCR,
CPR, BOM, Router, MPI/ SOP). Work on cost reduction projects to
reduce material/ process costs by defining and implementing new
techniques and equipment/ fixtures for assembly and test.
This may require designing fixtures and implementing in manufacturing
facilities.
Review and approve test methods for new devices being developed
in the department.
Requirements:
Experience in medical or surgical devices, and implantable biomaterials.
Excellent communication skills, and problem solving skills.
Ability to plan and schedule multiple projects and tasks.
Fluent in Spanish a plus.
Need to be able to make rapid and sound decisions.
Good knowledge of MS Office Suite and MS Project and basic knowledge
of SolidWorks.
Train techs and assemblers, project management skills. Essential:
BS or MS degree in Engineering. At least 3 years work experience
in related field.
Senior Product Manager (Medical Device)
Northern CA
Responsibilities:
The Senior Product Manager is responsible for developing promotional
materials and programs that will help meet the sales objectives
for their product line. The Senior Product Manager should use
communications with customers and the sales force to reinforce
a Company commitment and focus on customer satisfaction. The Senior
Product Manager should work closely with the field sales representatives
to support and enhance current products.
Qualifications:
Requires a BA or BS degree (MBA a plus)
4 - 5 years of medical sales and marketing experience.
Must possess in-depth understanding of how the products are used
and of factors that can influence the buying decision.
Must have a good understanding of the medical environment to effectively
respond to market concerns and provide technical support for the
products.
Experience working with external vendors and design companies
to produce written materials, and ability to work well with internal
personnel from all departments is essential in order to successfully
manage the product line.
International medical marketing experience is a plus.
Must have excellent verbal and written communication skills and
knowledge of office equipment and word processing.
Senior Quality Engineer (Medical Device)
Northern CA
Requirements:
Provide expertise and guidance to product development teams in
the area of design assurance, design controls and compliance.
Develop, establish and maintain quality engineering methodologies,
systems and practices that meet company, customer and regulatory
requirements.
Proactively investigate, identify and implement best-in-class
quality engineering practices.
Identify and implement effective process control systems to support
the development, qualification and on-going manufacturing of products
to meet or exceed internal and external requirements.
Develop and validate measurement methods, monitor design control
standards, facilitate and perform internal audits, perform statistical
analysis and participate in MRB as appropriate.
Perform internal audits, supplier assessment and generate audit
reports to support findings and/or assessment.
Act as Deputy Management Representative (if required) and as a
liaison with and an escort to the Notified Body.
Assist with preparation of regulatory submissions.
Process complaints and analyze returned products and recommend
corrective action.
Assist in and perform GMP training.
Development of standard operating procedures, and training.
Design and implement methods and procedures for inspecting, testing
and evaluating components, sub-assemblies and final assemblies.
Supervise employees as assigned.
Serve as Quality representative to provide awareness, visibility
and communication on quality initiatives to support departmental
and corporate quality goals and priorities.
Carry out responsibilities in accordance with the organizations
policies and applicable laws.
Requirements:
This position requires at least 8 years medical device experience
and a BS degree in engineering or equivalent.
Masters of Science degree a plus.
Demonstrated use of quality tools/methodologies.
Must have excellent leadership, communication and project management
skills.
Familiarity with FDA QSR (21 CFR Part 820 & Part 11) and ISO
13485/MDD requirements are required.
Must have working knowledge and experience in the following areas:
Design Control, Design & Process Validation, Biocompatibility,
Sterilization Validation, Packaging Validation, etc.
R&D Engineer (Medical Device)
Northern CA
Requirements:
B.S. in engineering preferably mechanical/chemical or equivalent
5 years experience in the medical device industry (preferably
cardiology, neurovascular areas)
Familiar with Design Control and GMP regulations
Recent balloon and other catheter development experience
Ability to write detailed verification and validation protocols
and reports
Proficient in Solid Works/autocad and modeling
Injection molding, extrusion experience
Familiar with catheter material properties, assembly techniques
and composite structures
Senior Manufacturing Engineer (Medical Device)
Northern CA
Responsibilities:
Limited manufacturing floor support will also be required.
Provide manufacturing engineering support to R & D project
teams, and coordinate transfer of new products into manufacturing.
Effectively analyze, develop, and implement corrective actions
to resolve product, process and system issues resulting in process,
yield and efficiency improvement.
Troubleshooting/resolving new and existing products/process problems
as related to design, material or manufacturing.
Develop process parameters for new equipment.
Write and execute Installation Qualification documentation for
new equipment.
Write protocols and reports for Operational Qualification and
Process Performance Qualification.
Release of process documentation for new processes and training
of production personnel.
Participate in the development of FMEA and other risk assessment
documentation.
Provide manufacturing engineering expertise and assist purchasing,
quality and R & D departments.
Interface with vendors, and suppliers as necessary.
Perform root cause analysis of returned products.
Requirements:
B.S. in Mechanical Engineering
6-10 years experience in the medical device manufacturing field
MUST have NPI experience.
Minimally invasive catheter experience needed
SolidWorks/AutoCAD proficiency, and ability to read and interpret
engineering drawings.
Hands-on individual with proven track record of resolving materials,
process, equipment, or training issues on production floor efficiently.
Ability to plan and implement projects from concept to completion.
Working knowledge of FDA QSRs and ISO 13485.
Some travel to vendor/supplier facilities required.
Manufacturing Engineer (Medical Device)
Northern CA
Responsibilities:
Design and develop manufacturing processes for new products,
product changes and enhancements, and related tooling and fixtures
which are consistent with a zero defect level as well as low product
cost.
Create and maintain tool drawings and shop orders in coordination
with the Quality Assurance and R&D functions.
Coordinate work of assigned technicians and temporary workers
as needed.
Plan and schedule projects in a manner consistent with corporate
objectives.
Contribute to the intellectual property position of the company
via invention and patent applications.
Maintain accurate documentation of concepts, designs, and processes.
Maintain current knowledge of medical, technical, and biomedical
developments as related to company products.
Support prototype and pilot production of new products, product
changes, and enhancements in coordination with the Manufacturing
and Quality Control functions.
Participate in facilities engineering and planning when appropriate.
Work with product development staff to ensure that products under
development are optimally manufacturable and to resolve manufacturing
issues.
Procure and oversee outside vendors and consultants as required.
Maintain GMP systems, including pre-production quality assurance
as well as post production GMP compliance in coordination with
Document Control, R&D, and Quality Assurance functions.
Complete accurate and timely manufacturing documentation including
manufacturing procedures, materials records, etc.
Support company goals and objectives, policies and procedures,
Good Manufacturing Practices, and FDA regulations.
Requirements:
BSME or MSME
2 to 5 years of experience (MSME requires no experience)
Working knowledge of standard machine shop equipment is required.
Proficiency with CAD software is required
Product Development Engineer (Medical Device)
Florida
Responsibilities:
Solicit and incorporate inputs from surgeons, marketing, sales,
service, manufacturing, quality, other engineering functions,
and external customers and partners
Support the design and development of implant products including
computational and mechanical simulations, 3D models, 2D drawings,
material selection, inspection requirements, and manufacturing
process requirements
Procure and evaluate prototypes including rapid prototypes, external
vendors, and internal
Support implant testing, verification, and validation, using sound
engineering problem-solving techniques including FEA analysis,
computational simulations, mechanical testing, and cadaver evaluations.
Support development of testing strategy, protocols, reports, and
data collection.
Support development efforts between all team members (internal
and external) including instrumentation, robotics, software, surgical
systems, and system integration as required
Requirements:
BS in engineering preferred
5+ years of orthopaedic device (hip or knee) experience
Experience with orthopaedic device Materials, Manufacturing processes
and procedures, Quality inspection processes and procedures, Packaging
processes and procedures, Sterilization processes and procedures
Product Marketing Manager (Medical Device)
Florida
Requirements:
Bachelors in Business/ Marketing or Science Related Discipline
3 -10 years of technical or marketing experience in medical device
industry (orthopedics, imaging or navigation preferred)
Demonstrated ability to plan, organize, manage and execute on
several marketing projects simultaneously, within budget
Current experience in arthroscopy, sport medicine, or orthopedic
surgery.
Relationships with thought leaders in orthopedics (specifically
with knee surgeons).
Experience launching an orthopedic product to the orthopedic sports
medicine community, knowledge of regulatory issues
Senior Quality Engineer (Medical Device)
Florida
Responsibilities:
Develops Quality Assurance Plans for new products. This may include
control plans, capability studies, measurement method analysis,
SPC, etc.
Participate in design reviews by identifying design weaknesses
and risks associated with the product use and tracking the mitigation
of those issues throughout the development process.
Manage the hazard analysis process.
Define design verification and validation test requirements to
assure appropriate objective evidence is available to support
the acceptance criteria. Ensure the design team applies efficient
testing methodologies (e.g. DOE).
Complete or contribute to the completion of final design verification
and design validation test reports by providing clear concise
conclusions with statistical validity and graphical support when
necessary.
Utilize standard statistical analysis and problem solving techniques
to determine product acceptance limits and process parameter limits
that promote robust design and manufacturing.
Recommend and define reliability methods that will enable the
achievement of our product reliability goals (e.g. HALT, HASS,
reliability growth, apportionment, worst case circuit analysis,
etc.).
Identify supplier assessment requirements and perform supplier
audits.
Support quality system maintenance primarily for the design control
process by identifying and correcting deficiencies in our procedures
and practices.
Identify and trend quality issues associated with NPD (e.g. FRACAS).
Lead CAPA teams in the analysis and resolution of product quality
issues.
Evaluate product design changes for qualification and validation
requirements and assist in change implementation.
Lead and/or participate in company internal audits.
Develop and deploy training to employees on QSR, ISO and company
Quality System requirements.
Requirements:
Strong statistical skills (e.g. ANOVA, distribution analysis,
DOE, significance tests, process capability, sampling plans, regression,
GR&R, etc.).
Knowledge of QSR and ISO 13485. Design control experience with
medical devices is preferred.
Minimum 5 years of quality engineering experience in NPD or manufacturing
of medical devices.
BSME, BSEE, BSBME preferred.
Masters degree in a related field is a plus.
American Society for Quality, Certified Quality Engineer (CQE)
preferred.
American Society for Quality, Certified Reliability Engineer (CRE)
is a plus.
Training or certification in Six Sigma and Lean Methods is a plus.
Reliability Test Engineer (Medical Device)
Florida
Responsibilities:
Develop testing protocols and equipment for new medical robotic
systems.
Work on cross-functional teams with mechanical, electrical, and
robotic engineers to develop testing protocols and equipment.
Develop reliability improvement and testing program with assistance
from outside consultants
Lead internal reliability testing activities and coordinate outside
reliability testing activities
Work with Project Teams to develop verification protocols to verify
system requirements
Work with Test Team to ensure system passes IEC 60601-1 safety
and EMC testing at external test lab
Analyze and document results of verification and reliability testing
Requirements:
3+ years experience developing tests for complex electromechanical
systems
Experience with reliability engineering techniques (HALT, HASS,
etc.)
Experience with robotic/haptic systems a plus
Experience with FDA/CE/ISO design control procedures a plus
Experience with IEC 60601-1 or similar testing a plus
Formal training in statistics or reliability engineering a plus
Certified Reliability Engineer (CRE) through the American Society
for Quality (ASQ) strongly preferred
BS degree in appropriate technical field required
Product Manager (Medical Device)
Northern CA
Description:
Manage the product lifecycle process, including product development,
product launch and on-market management.
Sheppard products through development process, identifying customer
needs and related design specifications.
Support regulatory process for assigned products, understanding
Class I - III requirements.
Manage all pre-launch customer preference testing (e.g., Physician
Preference Tests (PPT)) and data gathering in preparation for
product launch).
Develop new product launch plans, including product positioning
and promotional collateral to maximize penetration.
Create revenue forecast models for new products and impact on
existing product portfolio.
Create instructions for use and technique guides through interaction
with clinical champions for each new product.
Evaluate product performance and conduct continual improvement
efforts to increase utilization and improve customer satisfaction.
Monitor and report on competitive activity.
Requirements:
Bachelors degree or equivalent. MBA or equivalent experience
a plus.
A minimum of two years experience in a product marketing function
with a proven track record of success.
A background in medical devices or healthcare products and in
hospital-based sales models is highly preferred.
Project management and small group leadership abilities/experience.
A minimum of 30% travel.
Regulatory Affairs Specialist (Medical Device)
Northern CA
Description:
Assist in the development and maintenance of domestic regulatory
submissions, including 510(k), Letters to File, Investigational
Device Exemption (IDE), Premarket Approval Applications (PMA)
and PMA Supplements; and annual reports for both IDE and PMA.
Develop and maintain international regulatory submissions including
Technical Files, registrations/licenses and Design Dossiers for
CE marking, and those required for Canada, Latin America, Asia
and other Pacific Rim countries and other countries outside the
US (OUS).
Participate on product development teams from a regulatory perspective
including design control, FMEA, design and process validation,
clinical protocol development, and associated documentation including
written regulatory assessments for inclusion into the Design History
Files.
Review and approve Engineering Change Orders including assessments
of regulatory impact.
Act as a liaison between overseas employees, distributors, and
other foreign subsidiaries to facilitate product approval and
product usage OUS including providing appropriate documentation
for product registrations, licenses, clearances and approvals
OUS.
Requirements:
BS or BA in life sciences, or equivalent
Two to five years experience in Regulatory Affairs or related
equivalent experience in the medical device industry.
Experience with 510(k) and/or PMA and/or IDE submissions culminating
in the timely approval of those submissions.
International regulatory experience preferred, including experience
with product registrations and CE Technical Files.
Clinical study involvement preferred but not required.
Compliance experience desired, including experience with customer
complaint processing, MDRs, and Vigilance reporting.
Project management experience desirable.
Regulatory Affairs Manager (Medical Device)
Northern CA
Description:
Assist in the development and maintenance of domestic regulatory
submissions, including 510(k), Letters to File, Investigational
Device Exemption (IDE), Premarket Approval Applications (PMA)
and PMA Supplements; and annual reports for both IDE and PMA.
Develop and maintain international regulatory submissions including
Technical Files, registrations/licenses and Design Dossiers for
CE marking, and those required for Canada, Latin America, Asia
and other Pacific Rim countries and other countries outside the
US (OUS).
Participate on product development teams from a regulatory perspective
including design control, FMEA, design and process validation,
clinical protocol development, and associated documentation including
written regulatory assessments for inclusion into the Design History
Files.
Review and approve Engineering Change Orders including assessments
of regulatory impact.
Act as a liaison between overseas employees, distributors, and
other foreign subsidiaries to facilitate product approval and
product usage OUS including providing appropriate documentation
for product registrations, licenses, clearances and approvals
OUS.
Requirements:
BS or BA in life sciences, or equivalent
Five to eight years experience in Regulatory Affairs or related
equivalent experience in the medical device industry.
Experience with 510(k) and/or PMA and/or IDE submissions culminating
in the timely approval of those submissions.
International regulatory experience preferred, including experience
with product registrations and CE Technical Files.
Strong organizational, communications and leadership skills.
Exceptional writing skills required.
Good ability to analyze and present data desirable.
Clinical study involvement preferred but not required.
Compliance experience desired, including experience with customer
complaint processing, MDRs, and Vigilance reporting.
Familiar with applicable QSR, GMP, and ISO requirements.
Project management experience desirable.
Computer literate in MS Office and Word.
Senior Quality Engineer (Medical Device)
East TX
VERY STRONG Medical Device company seeking Top Talent to support
continued growth.
Description
Responsible for ensuring quality of products by providing quality
tool support in new product development, current product maintenance,
and systems development. This individual will be key in incorporating
new techniques into the NPCP as well as providing supplier quality
support.
This quality engineer will provide support for the disposable
product lines.
Requirements
BS, Materials, Mechanical, Chemical, or Biomedical Engineering.
Prefer ASQ certification.
5 to10 years in quality engineering; medical device industry strongly
preferred.
At least 2 to 5 years working with medical device sterilized disposables
or devices.
Extensive experience with Polymers, New Product Development, Product
Verification and Validation and Materials Testing.
Able to effectively communicate highly technical information to
both technical and non technical associates.
Experience in regulated design environments, specifically medical
device development, FDA or ISO registered work experience.
Regulatory experience with UL and IEC standards.
Six Sigma expertise demonstrated in manufacturing and design of
new products.
Ability to deal effectively with all employees and external business
contacts while conveying a positive, service oriented attitude.
Ability to communicate effectively, both verbally and in writing.
Product Development Engineer III (Medical Device)
East TX
VERY STRONG Medical Device company seeking Top Talent to support
continued growth.
Description
The position will be responsible for leading multifunctional teams
to design and develop products that meet requirements determined
by marketing inputs, from concept through commercialization.
Additional responsibilities include lead a cross-functional development
team for new embedded projects.
Work closely with marketing and medical to define new products.
Manage project timelines.
Manage project budgets.
Manage deliverables according to design controls.
Design and monitor verification, validation, and any field testing.
Liaise with regulatory to ensure all US and International claims
are met, i.e. 510k, CE.
Manage transfer of project from design to manufacturing.
Liaise with marketing, sales, and supply chain departments to
ensure successful product launch.
Monitor commercialized product through post launch surveillance.
Requirements
Bachelor degree in Mechanical, Electrical, Biomedical engineering
or equivalent medical device design experience.
PE license and, or PMP certification preferred.
5 to 8 years experience in medical device Research and Development.
Highly motivated, proven leader.
Excellent interpersonal skills.
Excellent problem solving skills.
Experience in Embedded device development highly preferred.
Experience in Research and Development of wound care devices preferred.
Experience in interacting with clinicians preferred.
Experience in sterilization methods preferred.
Experience with development of embedded devices, extrusions, injection
molding, packaging, and labeling preferred.
Senior Project Engineer (Medical Device)
GA
Overview:
Position leads project teams and/or provides technical effort
toward the development and introduction of new products and line
extensions into the medical device market. The position plays
a key role in leading teams through the development and FDA compliance
issues involved with medical devices. The position requires the
development of an understanding of the current medical device
markets and customer requirements along with the ability to interact
with doctors and other medical professionals.
Responsibilities:
- Assist in specifying performance criteria against which a candidate
product design must be challenged.
- Presents prototypes/proposed products in marketplace and draw
conclustions relative to user attitudes/acceptance of the device/system.
- Assist in ensuring the QSR compliance of design control process
in product development.
- Documents the new product development process: e.g. create specifications,
define testing protocols, prepare comprehensive performance reports,
and comply with QSR requirements.
- Performs patent searches, read patents, and comprehend patents.
- Brainstorms new inventions or solutions to current problems.
Manages complex programs and sets direction for large technical
efforts.
- Interfaces with senior management, customers, doctors, and vendors
regarding complex technical issues.
- Conceives, plans, and conducts research on development projects.
Qualifications:
Detail oriented and ability to organize large amounts of work
and data. Strong interpersonal skills required in areas of verbal
and written communications, customer focus, telephone manner,
time management, professionalism, coaching, influencing and team
building. Proficient in the use of a personal computer. Strong
listening, assessment, questioning and problem-solving skills.
BS degree in technical field such as biomedical engineerinbg,
polymer science, chemistry, chemical engineering, mechanical engineering.
Knowledge and training of project management, QSR, process development
and/or design control processes. Minimum of five years experience
in consumer/medical product and process development.
Senior R&D Engineer (Medical Device)
Northern CA
Overall Responsibilities:
Candidate should have a solid fundamental background in engineering
or the physical sciences with medical device design and research
experience.
Exposure to different medical devices and industrial technologies
and processes preferred.
Strong mechanical design background with examples of proven aptitude
in medical devices
Experienced in prototyping with proven hands-on skill.
An inventive aptitude (a passion for inventing) with proven ideation
skills and desire.
Demonstrable understanding of broad technologies and their uses.
The ability to combine ideas and apply concepts generally.
Good clinical background with ability to understand technologies
outside of immediate knowledge set and aptitude for assessing
selected technologies for clinical utility.
Ability to handle early research and development ambiguity with
strength in developing structure, planning experiments, executing
on selected activities, and flexibility to change direction as
required.
Ability to design and execute experiments, plan and complete animal
studies, and review, analyze and summarize data and results.
Candidate should be capable of reviewing and assessing intellectual
property as a tool to guide research and ideation.
Candidate should be capable of working with minimal supervision.
Ability to research and execute independently. However, equally
capable of collaboration and teamwork.
Desired Qualifications and Experience:
Hands-on medical device design and fabrication skills including
catheters and disposable instruments.
Experience with polymers and associated joining & shape-modification
methods
Catheter/delivery system design and fabrication experience including:
necking, laminating, braiding, tip forming, hub adaption, etc.
Some project lead or management experience a plus
Experience working with physicians is a plus
B.S. in Engineering or physical sciences equivalent with 6 or
more years of progressive experience. Medical device development
strongly preferred, or
M.S. in Engineering or physical sciences with 5 or more years
of progressive experience.
Medical device development strongly preferred.
Knowledge of Good Manufacturing Practices (GMP) and applicable
Quality System Requirements.
Ability to perform activities to support product development,
administration, manufacturing, and other company activities as
identified by Senior Management.
Principal Product Development Engineer (Medical Device)
MA
Need STRONG EE for this privately held Medical Device company.
This company is focused on bringing breakthrough products for
vascular occlusive disease to market. Join a company looking for
Leadership while having FUN.
Competencies:
MSEE or equivalent; PhD preferred.
Greater than 10 years of pertinent electrical engineering experience.
Significant experience with active medical devices within the
Vascular, Endovascular and Coronary markets preferred
Responsibilities:
Knowledge of FDA, IEC, UL and other regulatory requirements governing
medical devices.
Extensive experience in commercializing medical devices and executing
design controls.
Proven leadership skills and demonstrated knowledge of project
management.
Serve as the technical liaison to the end user to ensure all products
meet or exceed customer expectations.
Develop product specifications by interfacing with customers and
marketing personnel.
Participate in the development of new and revised products with
design contributions.
Create and responsible for engineering related documentation for
new and revised products.
Attend, participate in and report on pre-clinical and clinical
activities.
Specify appropriate tests, statistical methods and analyses related
to product development.
Debug, test and verify new designs.
Lead in design reviews.
Primary project / technical liaison to vendors or contractors
involved in development of products.
Lead the development of new and revised products and design essential
electronic circuitry, and software.
Coordinate or supervise EE related tasks such as microcontroller
programming, printed circuit board layout and prototype construction.
Prescribe and supervise verification of new designs.
Manage new product development projects.
Review all electrical engineering and software engineering technical
aspects of product development.
Assist other engineering disciplines in solving complex technical
problems.
Lead and Mentor engineers and technicians.
Skills:
Innovative and independent problem solver, mature, self-starter,
good communication skills.
Proficient with various engineering and business software applications.
Excellent organizational and product development process skills.
Amplitude modulation voltage drives.
HW/SW System integration.
HW/SW signal processing and analysis.
Closed feedback system control, especially for resonant circuitry.
Senior Quality Engineer (Medical Device)
Northern CA
Responsibilities:
Implement, support, and sustain elements of quality system through
procedure generation, training, auditing, and technical support.
The quality engineer serves as a key resource for ISO, EN, MDD,
and QSR requirements.
Ensure compliance to electrical safety standards: IEC60601-1,
IEC60601-1-1, IEC 60601-1-2, IEC 60601-2-2, UL 60601-1 along with
any product specific safety standards.
Perform bench-top testing on electrical generators per the requirements
of the IEC and UL standards.
Generate/approve validation studies, capability studies, FMEA/Hazard
analysis.
Collaborate with engineering, manufacturing, and regulatory, and
work with outside labs and suppliers.
Support manufacturing operations in Costa Rica.
Ensure that compliance to cGMP and EN/ISO 9001/13485/MDD requirements
are maintained.
Ensure that all the responsibilities within the scope of this
job comply with the scope of the Quality System.
Requirements:
Requires a team player with a bachelor's degree in engineering
or life sciences, minimum 5 years related experience and 1-3 years
experience in the medical device industry or product safety testing.
Must be able to perform the testing specified in the IEC and UL
standards.
Must be able to provide and implement solutions to quality problems.
Requires the ability to understand the impact of GMP's, ISO 9001/13485,
and MDD requirements on new products.
Must have effective written/oral communication skills. MS Office,
Excel, Statistical software.
ASQ member (preferred).
