Sr. Product Development Engineer

About the role

Join the medical device team to lead the mechanical design of consumer medical devices and validate their packaging systems. This role involves hands-on work from initial concept to design transfer, ensuring all technical, regulatory, and performance standards are met. Your focus will be on human factors and usability in creating safe, compliant products.

Key facts

What you'll do

• Design and develop medical devices, including concept creation, detailed design, prototyping, and transfer to manufacturing.
• Produce and maintain compliant design documentation, such as design inputs, outputs, DHFs, and engineering change orders.
• Conduct design verification and validation (V&V) activities, from writing test protocols to execution and reporting.
• Lead or assist with human factors engineering (HFE), including use-related risk analysis and usability testing.
• Apply risk management principles throughout the product development cycle.
• Create and evaluate prototypes using various fabrication methods, iterating quickly based on feedback.
• Support production readiness and collaborate with contract manufacturers to optimize cost, quality, and scalability.
• Assess and qualify packaging materials, components, and configurations for device protection, usability, and shipping integrity.
• Lead packaging qualification activities, including seal strength, integrity testing, and aging studies.
• Lead or support sterilization validation efforts with external partners.
• Organize transportation and distribution simulation testing to maintain product integrity in the supply chain.
• Maintain comprehensive packaging and device documentation within the DHF and DMR.
• Contribute to regulatory submissions through engineering documentation and technical file development.
• Work with Quality, Regulatory Affairs, Operations, Supply Chain, and Creative Design to prepare devices and packaging for commercialization.
• Coordinate testing with external laboratories, sterilization vendors, and packaging suppliers.
• Support Regulatory Affairs with submissions and documentation for devices, packaging, and sterilization.
• Participate in design reviews, internal audits, supplier assessments, and regulatory inspections.
• Contribute to risk management for devices, packaging, shipping, and product transport.

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Packaging Engineering, or a related field.
• 8+ years of engineering experience, with at least 4 years in FDA-regulated medical device or diagnostics product development.
• Knowledge of 21 CFR 820 (QSR), ISO 13485, and ISO 11607 quality and packaging standards.
• Practical experience with design controls, DHF documentation, and design V&V.
• Experience writing 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 usability testing.
• Proficient in SolidWorks or similar 3D CAD software, with experience in 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

• Experience with diagnostic specimen collection, sample integrity, or diagnostic consumable development (e.g., blood collection, lateral flow, or microfluidic devices).
• Familiarity with CLIA regulations, laboratory interfaces, or point-of-care diagnostic platforms.
• Advanced HFE experience, including full summative usability study design and execution, moderating use scenarios, and generating HFE reports 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 interaction during submission.

Skills & tools

• SolidWorks
• 3D CAD software
• GD&T
• Tolerance stack-up analysis

Practical notes

• This role involves working with Hazardous Drugs (HD), requiring specific Personal Protective Equipment (PPE) such as gloves, respiratory protection, and gowns.
• Medical approval to wear negative or positive pressure respirators (N95, full face, SCBA, PAPR) is required.
• Physical exertion is necessary, including walking up to 50% of the time, standing up to 100%, squatting and bending up to 20%, and lifting up to 80% for up to a twelve-hour shift. Must be able to lift up to 50lbs.
• Confirmation of understanding potential risks (teratogenicity, carcinogenicity, reproductive effects) of handling hazardous drugs is required.
• Benefits include competitive salary and equity, unlimited PTO, company holidays, quarterly mental health days, comprehensive health benefits, parental leave, Employee Stock Purchase Program (ESPP), employee discounts, 401k with employer matching, and offsite team retreats.