The posting, in Hims & Hers's own words
archived Oct 15, 2026Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals .
About the Role:
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. Your focus is on ensuring the medical device and packaging solutions meet all technical, regulatory, and performance requirements, including strong attention to human factors and usability. 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.
Read the full posting ↓
Device & Packaging Development
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. Execute design verification and validation (V&V) activities, including test protocol authorship, execution, and reporting. Lead or support human factors engineering (HFE) activities, including use-related risk analysis and formative/summative usability testing. Apply risk management principles throughout the product development lifecycle. Develop and evaluate prototypes using appropriate fabrication methods; iterate rapidly based on testing and user feedback. Support design for production readiness and work with contract manufacturers and suppliers to optimize cost, quality, and scalability. Evaluate and qualify packaging materials, components, and configurations for device protection, usability, stability, and shipping integrity. Lead packaging qualification activities including seal strength testing, package integrity testing, and accelerated and real-time aging studies. Lead or support sterilization validation activities in partnership with external vendors and laboratories. Coordinate transportation and distribution simulation testing to ensure product integrity through the supply chain. Maintain complete packaging and device documentation within the DHF and DMR. Contribute to regulatory submissions through engineering documentation and technical file development.
Cross-Functional & Regulatory Collaboration
Collaborate with Quality, Regulatory Affairs, Operations, Supply Chain, and the Creative Design team to ensure device and packaging readiness for commercialization. Coordinate testing activities with external laboratories, sterilization vendors, and packaging suppliers. Assist Regulatory Affairs with submissions and documentation related to device, packaging, and sterilization. Participate in design reviews, internal audits, supplier assessments, and regulatory inspections as needed. Contribute to risk management activities related to the device, packaging, shipping, and product transport.
You Have (required):
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.