Job Description
Job Description
Technical Skills
Must Have
- Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively.
- Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., Product Hazard Analysis, Design and Process FMEA, User Analysis).
- Experience in the application of statistics.
- Experience with Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering.
- Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA).
- Experience with implantable medical devices.
- Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results.
- Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work.
Nice To Have
• A self-motivated learner who actively seeks out new knowledge, skills, and solutions to adapt to evolving challenges.
• Experience with data analytics
Top 3 skills sets required:
- At least 3 years of experience with ISO 14971 in a medical device company
- At least 3 years of experience creating or maintaining risk management files for medical devices
- At least 3 years of experience working with Quality Design Control deliverables
3 main responsibilities/day to day activities required for this role:
- Updating and Maintaining Risk Management Files for Class III Medical Devices
- Working with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.
- Collaborating with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.
What products (if any) will this role support?
- Spinal Chord Stimulation, Deep Brain Stimulation, Pelvic Health
What is your target years of experience?
- At least 5 years of experience within Medical Device
Qualifications
- Experience with implantable medical devices.
- Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., Product Hazard Analysis, Design and Process FMEA, User Analysis).
- Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA).
- Experience with Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering.
- Experience in the application of statistics.
- Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work.
- Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively.
- Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results.