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.

What Youll Do

Mechanical Design & Product Development

• 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

Design Controls & Documentation

• 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

Test Development & Verification

• 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

Cross-Functional Collaboration

• 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

What Were Looking For

Required:

• Bachelors 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 SolidWorks 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

What Youll Bring

• 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

Compensation & Benefits

• 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
• Professional development opportunities
• Hybrid schedule three days per week onsite

Where Youll Work

This role is based at a 35000 sq. ft. state-of-the-art innovation facility in Newark NJ purpose-built to support deep tech and healthcare startups. The space includes advanced engineering workshops prototyping equipment and wet lab capabilities enabling rapid product development. The location is within walking distance of two major transit stations with approximately 20-minute train access from Manhattan.

Equal Opportunity Statement

This employer is committed to building a diverse and inclusive team. All qualified applicants will be considered without regard to race color religion sex sexual orientation gender identity national origin age disability veteran status or any other characteristic protected under applicable federal state or local law.