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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
More about this role
Hims & 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 .
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...
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