Senior Medical Device Engineer: Packaging & Usability

hims & hers; Minnetonka (MN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO

Comprehensive health benefits

ESPP

Employee discounts on products

401k with employer matching

Offsite team retreats

Job summary

Hims & Hers is seeking a Senior Product Development Engineer to join our medical device team. You will design and validate consumer medical devices and their packaging from concept through design transfer, ensuring compliance and usability.

Experience with IVD/diagnostic devices is a plus, and the role emphasizes safety, quality, and scalable manufacturing. You will collaborate across Quality, Regulatory, Operations, and Supply Chain to align on packaging readiness and regulatory submissions,

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Packaging Engineering, or a closely related field.
• 8+ years engineering experience with at least 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.

Responsibilities

• 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 activities, including test protocol authorship, execution, and reporting.
• Lead or support human factors engineering 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.

Skills

Engineering experience

FDA-regulated devices

V&V design

DHF documentation

HFE activities

SolidWorks

GD&T

ISO 14971

Cross-functional collaboration

Regulatory submissions support

Education

Bachelor’s degree in Mechanical/ Biomedical/ Packaging Engineering or related

Job description

Hims & Hers is seeking a Senior Product Development Engineer to join our medical device team. You will design and validate consumer medical devices and their packaging from concept through design transfer, ensuring compliance and usability.

Experience with IVD/diagnostic devices is a plus, and the role emphasizes safety, quality, and scalable manufacturing. You will collaborate across Quality, Regulatory, Operations, and Supply Chain to align on packaging readiness and regulatory submissions,