Sr. Product Development Engineer

Hims & Hers•Boston, MA

4d•$130,000 - $150,000

About The Position

Hims & Hers is seeking a Senior Product Development Engineer to join its medical device team. This hands-on individual contributor will design consumer medical devices and develop and validate their packaging systems, from concept through design transfer. The role ensures that device and packaging solutions meet technical, regulatory, usability, and performance requirements. Experience with IVD or diagnostic device development is beneficial as the product portfolio grows. The engineer will generate and develop concepts, create prototypes, prepare design-control documentation, and execute verification and validation. The role also encompasses human factors engineering, risk management, packaging qualification, sterilization validation, and transportation simulation. The engineer will support production readiness and design transfer while working with contract manufacturers, suppliers, external laboratories, and internal partners across Quality, Regulatory Affairs, Operations, Supply Chain, and Creative Design. The role contributes engineering documentation and technical files for regulatory submissions and maintains device and packaging records in the DHF and DMR. The position involves working with Hazardous Drugs and wearing required personal protective equipment, including respiratory protection. Medical approval is required to wear respirators. Physical exertion is required, including walking, standing, squatting, bending, and lifting up to 50 pounds. Associates must also be willing to confirm their understanding of potential risks from handling certain hazardous drugs.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Packaging Engineering, or a closely related field.
At least 8 years of engineering experience, including 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 verification and validation.
Experience authoring and executing packaging qualification or sterilization validation protocols and technical reports.
Experience conducting human factors engineering activities under FDA HE75 and IEC 62366-1, including use-related risk analysis and formative and 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 under ISO 14971.
Strong written and verbal communication skills for cross-functional collaboration and technical documentation.
Must obtain medical approval to wear negative- or positive-pressure respiratory protection, including N95, full-face respirator, SCBA, or PAPR.
Must be able to wear required PPE while working with hazardous drugs.
Must be able to lift up to 50 pounds and perform the physical exertion described in the posting.
Must be willing to confirm understanding of the potential risks of handling certain hazardous drugs, including teratogenicity, carcinogenicity, and reproductive effects.

Nice To Haves

Experience with diagnostic specimen collection, sample integrity requirements, or diagnostic consumable development, such as blood collection, lateral flow, or microfluidic devices.
Familiarity with CLIA regulations, laboratory interfaces, or point-of-care diagnostic platforms.
Advanced human factors experience, including designing and executing full summative usability studies, moderating use scenarios with target user populations, and producing human factors reports suitable for regulatory submission.
Experience applying IEC 62366-1 and FDA HE75 within a formal design-control process, including task analysis, use-error identification, and critical-task definition.
Experience with Class II or Class III medical devices and exposure to notified body or FDA interactions during submission.

Responsibilities

Design and develop medical devices from concept generation through detailed design, prototyping, and design transfer to manufacturing.
Create and maintain design-control documentation, including design inputs and outputs, DHFs, and engineering change orders.
Execute design verification and validation activities, including authoring and carrying out test protocols and reporting results.
Lead or support human factors engineering activities, including use-related risk analysis and formative and summative usability testing.
Apply risk management principles throughout product development.
Develop and evaluate prototypes using suitable fabrication methods and iterate based on testing and user feedback.
Support production readiness and collaborate 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 and package integrity testing, and accelerated and real-time aging studies.
Lead or support sterilization validation with external vendors and laboratories.
Coordinate transportation and distribution simulation testing to verify product integrity through the supply chain.
Maintain complete device and packaging documentation in the DHF and DMR.
Contribute engineering documentation and technical files for regulatory submissions.
Collaborate with Quality, Regulatory Affairs, Operations, Supply Chain, and Creative Design to support device and packaging commercialization readiness.
Coordinate testing with external laboratories, sterilization vendors, and packaging suppliers.
Assist Regulatory Affairs with submissions and documentation related to devices, packaging, and sterilization.
Participate in design reviews, internal audits, supplier assessments, and regulatory inspections as needed.
Contribute to risk management for devices, packaging, shipping, and product transport.