Overview In this role you lead a Human Factors team to apply perceptual, cognitive, and motor insights across the product lifecycle, ensuring regulatory compliance for all combination products and medical devices. You'll collaborate with the Device Development team and cross-functional groups to identify user needs, assess risk, design Usability and risk mitigations, and prepare regulatory materials. You influence strategy for innovative product design and oversee post-market surveillance. This is a hands-on leadership position in a regulated environment with a clear impact on patient safety and product success.
Compensation / Benefits- annual bonus
- long-term incentive
- medical, dental, vision insurance
- 401(k) retirement plan
- paid holidays
- vacation and sick days
Responsibilities- Lead and manage a Human Factors team applying HF methods across the product lifecycle (need identification, concept screening, task analysis, use error analysis, usability testing, hazard analysis, post-launch review).
- Coach and mentor junior scientists to support professional growth.
- Develop and execute human factors plans, gather customer needs, specify intended use and hazards, contribute to product and packaging inputs, design use instructions, and conduct formative and summative studies.
- Prepare regulatory submission materials and support post-market surveillance activities.
- Strategically plan HF assessments for innovative product design and collaborate with cross-functional teams to ensure regulatory compliance through risk management.
- Maintain development deliverables and documents (HF study protocols/reports, task analyses, use error analyses) and manage associated records/databases.
- Stay current with HF advancements in regulatory contexts and represent the company in external forums to influence practices.
- Support other quality and GMP compliance activities related to combination products and medical devices.
Key requirements- B.A./B.S in Human Factors, Ergonomics, Cognitive/ Experimental Psychology, Sociology, Engineering, Chemistry, or Business Management plus 10 years of related experience
- Strong knowledge of human factors, device regulatory requirements, and industry standards for device systems
- Experience in team and people management preferred
- Excellent communication, leadership, and problem-solving skills
- Ability to work in a dynamic, fast-paced environment with multiple priorities
- strategic thinking
- cross-functional collaboration
- problem-solving
- Human Factors
- Risk management
- Usability testing
