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. Experience with IVD or diagnostic device development is a plus and will be increasingly valuable as our product portfolio grows. This is a hands-on individual contributor role for someone who thrives in a fast-paced environment and is energized by building safe, compliant products that improve people's lives.
You Will:Device & Packaging Development- 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 (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.
- 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.
Cross-Functional & Regulatory Collaboration- Collaborate with Quality, Regulatory Affairs, Operations, Supply Chain, and the Creative Design team to ensure device and packaging readiness for commercialization.
- Coordinate testing activities with external laboratories, sterilization vendors, and packaging suppliers.
- Assist Regulatory Affairs with submissions and documentation related to device, packaging, and sterilization.
- Participate in design reviews, internal audits, supplier assessments, and regulatory inspections as needed.
- Contribute to risk management activities related to the device, packaging, shipping, and product transport.
You Have (required):- 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; 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.
Nice to Have:- IVD Experience: Experience with diagnostic specimen collection, sample integrity requirements, or diagnostic consumable development (e.g., blood collection, lateral flow, or microfluidic devices).
- IVD Experience: Familiarity with CLIA regulations, laboratory interfaces, or point-of-care diagnostic platforms.
- Human Factors: Advanced HFE experience including full summative usability study design and execution, moderating use scenarios with target user populations, and generating HFE reports suitable for regulatory submission.
- Human Factors: 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 interaction during submission.
Our Benefits (there are more but here are some highlights):- Competitive salary & equity compensation for full-time roles
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- Employee discounts on hims & hers & Apostrophe online products
- 401k benefits with employer matching contribution
- Offsite team retreats
Conditions of Employment:
- This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
- This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
- Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
- Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.
