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Hims & Hers, a leading telehealth and consumer health platform (NYSE: HIMS), is seeking a Senior Product Development Engineer to join its medical device team. This hands-on individual contributor role focuses on mechanical design and engineering validation of FDA-regulated consumer medical devices and their packaging systems, from concept through manufacturing transfer.
You will own the full product development lifecycle for medical devices, including concept generation, detailed design, prototyping, and design transfer to manufacturing partners. Key responsibilities include creating design-compliant documentation (design inputs/outputs, DHFs, ECOs), executing design verification and validation activities with test protocol authorship and execution, and leading human factors engineering (HFE) activities including use-related risk analysis and formative/summative usability testing. You'll develop and iterate prototypes rapidly, support design for production readiness, and work directly with contract manufacturers to optimize cost, quality, and scalability.
Packaging qualification is a major focus: you'll evaluate and qualify packaging materials, lead seal strength and package integrity testing, manage accelerated and real-time aging studies, coordinate sterilization validation with external vendors, and oversee transportation/distribution simulation testing. You'll maintain complete device and packaging documentation within the DHF and DMR, and contribute to regulatory submissions through technical file development.
Cross-functional collaboration is essential. You'll partner with Quality, Regulatory Affairs, Operations, Supply Chain, and Creative Design to ensure commercialization readiness. You'll coordinate with external labs, sterilization vendors, and suppliers; support regulatory submissions; participate in design reviews and audits; and contribute to risk management activities across device, packaging, and supply chain.
Required: Bachelor's in Mechanical, Biomedical, or Packaging Engineering. 8+ years engineering experience with minimum 4 years in FDA-regulated medical device or diagnostics development. Strong knowledge of 21 CFR 820 (QSR), ISO 13485, and ISO 11607. Hands-on experience with design controls, DHF documentation, and design V&V. Proven ability authoring and executing packaging qualification and sterilization validation protocols. HFE experience per FDA HE75 and IEC 62366-1, including use-related risk analysis and usability testing. Proficiency in SolidWorks or equivalent 3D CAD, GD&T, and tolerance stack-up analysis. Familiarity with ISO 14971 risk management.
Nice-to-have: IVD/diagnostic device experience (specimen collection, sample integrity, lateral flow, microfluidic devices), CLIA or point-of-care platform knowledge, advanced HFE with summative study design and execution, Class II or Class III device experience.
