Sr Human Factors Design Engineer – Medical Device

Hiring: Sr Human Factors Design Engineer – Medical Device

Location: Fridley, MN (Onsite – Rice Creek East)

Duration: 12 Months

Type: W2 Contract

About the Role

We are seeking a Senior Human Factors Design Engineer to support a cutting-edge medical device program focused on usability, safety, and regulatory compliance. This role will play a key part in summative studies and FDA submissions.

Key Responsibilities

• Lead summative study preparation and execution
• Conduct usability testing and user research
• Perform use-related risk analysis
• Collaborate with cross-functional teams (design, quality, regulatory)
• Support regulatory submissions (FDA/TÜV)

Top Skills Required

✔ Human Factors Engineering

✔ UX Research / Usability Testing

✔ FDA / Regulatory Submission Experience

Must-Have Experience

• Formative & Summative Studies
• Human Factors / Usability Engineering
• User Experience Research
• Risk Analysis (use-related)

Nice to Have

• 510(k) submission experience
• Experience with Deep Brain Stimulation (DBS)

Experience Required

• 3+ years (MS) or 5+ years (BS)
• Preferred: 5–15 years in Human Factors / Medical Devices.