Senior Product Development Engineer (Medical Devices)

TL;DR

Senior Product Development Engineer (Medical Devices): Designing and developing consumer medical devices and packaging systems within FDA-regulated environments with an accent on mechanical design and engineering validation. Focus on ensuring regulatory compliance, optimizing human factors, and managing design transfer from concept to manufacturing.

Location: On-site in Minnetonka, Minnesota

Salary: $130k – $150k

Company

A leading health and wellness platform redefining healthcare by providing accessible, personal, and affordable care from diagnosis to delivery.

What you will do

• Lead hands-on mechanical design of medical devices and packaging systems from concept through design transfer to manufacturing.
• Create and maintain FDA-compliant documentation, including design inputs, outputs, DHFs, and engineering change orders.
• Execute design verification and validation (V&V) activities, including test protocol authorship, execution, and reporting.
• Perform human factors engineering (HFE) and use-related risk analysis to optimize usability.
• Manage packaging qualification activities, including seal strength, integrity testing, and sterilization validation.
• Collaborate with Quality, Regulatory Affairs, and Supply Chain teams to ensure commercialization readiness.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, or Packaging Engineering.
• 8+ years of engineering experience, with a minimum of 4 years in FDA-regulated medical device or diagnostics product development.
• Proficiency in SolidWorks or equivalent 3D CAD software, including GD&T and tolerance stack-up analysis.
• Working knowledge of 21 CFR 820 (QSR), ISO 13485, and ISO 11607 quality and packaging standards.
• Experience authoring and executing packaging qualification or sterilization validation protocols.
• Ability to work on-site and pass medical approval for respiratory protection (PPE) due to handling hazardous drugs.

Nice to have

• Experience with IVD (In Vitro Diagnostics), specimen collection, or diagnostic consumable development.
• Advanced HFE experience including full summative usability study design and execution.
• Experience with Class II or Class III medical devices and direct interaction with the FDA during submissions.

Culture & Benefits

• Competitive salary and equity compensation.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive medical, dental, vision, and parental leave benefits.
• 401k with employer matching and Employee Stock Purchase Program (ESPP).
• Employee discounts on company products and offsite team retreats.