Sr. Product Development Engineer — Menlo Park, CA

The role

You will perform hands-on mechanical design of consumer medical devices and engineering validation of packaging systems. This role involves concept generation, prototyping, design transfer, and ensuring compliance with technical and regulatory requirements.

What you will do

• Design and develop medical devices from concept through design transfer to manufacturing.
• Create and maintain design compliant documentation including DHFs and engineering change orders.
• Execute design verification and validation activities.
• Lead or support human factors engineering activities.
• Apply risk management principles throughout the product development lifecycle.
• Develop and evaluate prototypes using various fabrication methods.
• Support design for production readiness and work with contract manufacturers.
• Evaluate and qualify packaging materials and configurations.
• Lead packaging qualification activities including seal strength and integrity testing.
• Lead or support sterilization validation activities.

Required qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Packaging Engineering, or a closely related field.
• 8+ years of engineering experience.
• 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.
• 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.

Nice to have

• IVD Experience: Experience with diagnostic specimen collection, sample integrity requirements, or diagnostic consumable development.
• IVD Experience: Familiarity with CLIA regulations, laboratory interfaces, or point-of-care diagnostic platforms.
• Human Factors: Advanced HFE experience including full summative usability study design and execution.
• Human Factors: Experience applying IEC 62366-1 and FDA HE75 within a formal design control process.
• Experience with Class II or Class III medical devices and exposure to notified body or FDA interaction.

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

Before you apply

• Requires working with Hazardous Drugs (HD) and wearing Personal Protective Equipment (PPE).
• Requires medical approval to wear respiratory protection.
• Requires physical exertion including standing up to 100% of the time and lifting up to 50lbs.
• Must be willing to confirm understanding of potential risks from handling hazardous drugs.

About the company

Hims & Hers is a health and wellness platform that provides access to affordable, accessible, and personal healthcare. It is a public company traded on the NYSE.