Mechanical Engineer

The Opportunity

This is a hands‑on mechanical engineering role with significant ownership over a next‑generation medical device platform from early development through manufacturing readiness. The right candidate will thrive in a fast‑paced startup environment, enjoy multidisciplinary engineering challenges, and want direct impact on a product that is redefining how patient health is monitored.

• Translate product and system requirements into robust, manufacturable mechanical designs
• Create and maintain 3D CAD models, assemblies, and detailed engineering drawings
• Drive design iterations through prototyping, engineering builds, and pilot production runs
• Own mechanical development from concept through verification and manufacturing readiness
• Lead DFM and DFA activities in collaboration with vendors and contract manufacturers
• Work on highly miniaturized electromechanical systems requiring tight integration across mechanical, electrical, firmware, and sensing technologies
• Support reliability, durability, and environmental protection considerations for wearable medical devices

• Develop and refine mechanical and system‑level requirements
• Generate and maintain Design History File (DHF) documentation in compliance with medical device design control requirements
• Contribute to risk management activities including DFMEA and usability considerations
• Support continuous improvement of engineering and product development processes

• Define test strategies, protocols, and acceptance criteria for mechanical and system performance
• Design and build custom test fixtures, tooling, and engineering test equipment
• Execute characterization, reliability, and verification testing
• Analyze and document test results and communicate findings across teams
• Support verification and validation activities leading into commercialization

• Partner with quality, operations, firmware, electrical engineering, and external manufacturing teams
• Support design transfer and production scale‑up
• Collaborate with suppliers and contract manufacturers to resolve technical and production challenges

Required:

• Bachelor’s degree in Mechanical Engineering or a related field
• 4+ years of product development experience in a regulated industry such as medical devices, aerospace, biotech, or automotive
• Strong proficiency in 3D CAD software—Solid Works preferred
• Experience working within FDA design control or comparable regulated development frameworks
• Demonstrated ability to design and execute engineering test plans and verification activities
• Hands‑on experience building test fixtures and prototype systems
• Direct experience working with external vendors, suppliers, and contract manufacturers
• Strong problem‑solving and root cause analysis capabilities
• Ability to work onsite four days per week

Preferred:

• Experience with wearable, miniaturized, or sensor-integrated device development
• Background in design transfer and manufacturing scale‑up
• Familiarity with injection molding, precision adhesives, sealing methods, and tight‑tolerance assemblies
• Experience with DFMEA and formal risk management methodologies
• Prior startup or early‑stage company experience
• Proficiency with rapid prototyping tools including 3D printing and benchtop fabrication
• Familiarity with statistical analysis, tolerance stack‑ups, or reliability testing methods

• Strong ownership mentality and willingness to roll up your sleeves on hands‑on technical work
• Ability to make sound engineering decisions with incomplete information and iterate quickly
• Comfort balancing speed with rigor in a regulated development environment
• Clear, proactive communication across both technical and non‑technical stakeholders
• Strong documentation habits and organizational discipline
• Curiosity, adaptability, and a continuous improvement mindset

• Competitive base salary with meaningful equity participation
• Medical, dental, and vision insurance
• 401(k) plan
• PTO, paid holidays, Summer Fridays, and Winter Break
• Commuter benefits for parking and public transit
• Professiona…