Senior Product Development Engineer

We are looking for a Senior Product Development Engineer with experience in FDA-regulated devices and packaging development to join our medical device team. You will work hands-on mechanical design of consumer medical devices and the engineering validation of their packaging systems, from concept through design transfer.

What You Will Do

Hands-on design and development of medical devices, including concept generation, detailed design, prototyping, and design transfer to manufacturing. Create and maintain design compliant documentation, including design inputs, outputs, DHFs, and engineering change orders.

Why It Might Be a Fit

Experience with IVD or diagnostic device development is a plus and will be increasingly valuable as our product portfolio grows. This is a hands-on individual contributor role for someone who thrives in a fast-paced environment and is energized by building safe, compliant products that improve people’s lives.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Packaging Engineering, or a closely related field.
• 8+ years of engineering experience, with a minimum of 4 years in FDA-regulated medical device or diagnostics product development.
• Working knowledge of 21 CFR 820 (QSR), ISO 13485, and ISO 11607 quality and packaging standards.
• Hands-on experience with design controls, DHF documentation, and design V&V.
• Experience authoring and executing packaging qualification or sterilization validation protocols and technical reports.
• Experience conducting human factors engineering (HFE) activities per FDA HE75 and IEC 62366-1, including use-related risk analysis and formative/summative usability testing.
• Proficiency in SolidWorks or equivalent 3D CAD software; experience with GD&T and tolerance stack-up analysis.
• Familiarity with risk management processes per ISO 14971.
• Strong written and verbal communication skills for cross-functional collaboration and technical documentation.

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• Employee discounts on hims & hers & Apostrophe online products
• 401k benefits with employer matching contribution
• Offsite team retreats