Senior Medical Device & Packaging Engineer

Hims; Minnetonka (MN); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

Equity compensation

Unlimited PTO and holidays

Comprehensive health benefits

ESPP

Employee discounts on products

401k with employer matching

Offsite team retreats

Job summary

Hims, based in Minnesota, seeks a Senior Product Development Engineer to lead hands‑on mechanical design of consumer medical devices and the validation of packaging systems from concept through transfer to manufacturing.

You will ensure devices and packaging meet regulatory requirements, emphasize usability, and contribute to safety and performance through design controls, V&V, and cross‑functional collaboration with Quality, Regulatory, Operations, and suppliers.

Qualifications

• 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; 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 from concept to transfer.
• Create and maintain design compliant documentation (DHF, inputs/outputs).
• Execute design V&V activities including test protocols and reporting.
• Lead or support human factors activities and usability testing.
• Apply risk management throughout the product lifecycle.
• Develop prototypes and iterate based on test results and user feedback.
• Support design for production readiness and collaborate with contract manufacturers and suppliers.
• Evaluate packaging materials and configurations for device protection and shipping.
• Lead packaging qualification tests and sterilization validation with external partners.
• Coordinate packaging testing for supply chain integrity.
• Maintain DHF and DMR documentation; support regulatory submissions.

Skills

Regulatory knowledge

HFE (Human Factors)

Risk management

Cross-functional collaboration

Technical communication

Education

Bachelor’s degree in Mechanical/BME/Packaging

Tools

SolidWorks

GD&T

3D CAD

Job description

Hims, based in Minnesota, seeks a Senior Product Development Engineer to lead hands‑on mechanical design of consumer medical devices and the validation of packaging systems from concept through transfer to manufacturing.

You will ensure devices and packaging meet regulatory requirements, emphasize usability, and contribute to safety and performance through design controls, V&V, and cross‑functional collaboration with Quality, Regulatory, Operations, and suppliers.