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Sr. Product Development Engineer
Hims & HersTelemedicine company
Minnetonka, United StatesSenior
Thrive Capital
Forerunner Ventures
8VC
About the role
TL;DR
Designs and develops FDA-regulated medical devices and packaging systems.
- •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.
- •Key Responsibilities Hands-on design and development of medical devices, including concept generation, detailed design, prototyping, and design transfer.
- •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.
- •Evaluate and qualify packaging materials, components, and configurations for device protection, usability, stability, and shipping integrity.
- •Contribute to regulatory submissions through engineering documentation and technical file development.
- •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.
- •Proficiency in SolidWorks or equivalent 3D CAD software; experience with GD&T and tolerance stack-up analysis.
- •Experience conducting human factors engineering (HFE) activities per FDA HE75 and IEC 62366-1.
Nice-to-have skills
Product ManagementUX Design
Domain expertise
healthtech
Benefits & perks
Competitive salary & equity compensation, Unlimited PTO, Company holidays, Quarterly mental health days, Comprehensive health benefits, Medical, Dental, Vision, Parental leave, Employee Stock Purchase Program (ESPP), Employee discounts, 401k benefits with employer matching contribution, Offsite team retreats