Senior Mechanical Design Engineer – Healthcare Manufacturing

Location: Remote, with head office in New York, NY

Travel: 25–35% (customer sites, manufacturing facilities, design reviews, and occasional HQ visits)

Reports to: Director of Engineering / Product Development

About the Role

We are seeking an innovative Mechanical Design Engineer with strong business acumen to join our product development team. This remote position supports the design, development, and commercialization of medical devices and healthcare manufacturing solutions. You will apply mechanical engineering expertise across the full product lifecycle—from concept and detailed design through validation, transfer to manufacturing, and continuous improvement—while collaborating with cross-functional teams, suppliers, and customers.

The ideal candidate brings hands-on experience in precision mechanical design (ideally spanning automotive and/or medical device environments), intellectual property generation, and the ability to balance technical excellence with commercial and manufacturing realities.

Key Responsibilities

• Lead mechanical design and development of medical device components, assemblies, mechanisms, and enclosures using CAD (SolidWorks, Creo, or equivalent).
• Perform detailed design work including kinematics, mechanisms, tolerance analysis, material selection, Design for Manufacturability/Assembly (DFM/DFA), and Design for Reliability.
• Generate and maintain design documentation (drawings, BOMs, specifications, design history files) in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulations.
• Support prototype builds, verification & validation testing, root-cause analysis, and design iterations.
• Collaborate with manufacturing partners (contract manufacturers), quality, regulatory, and supply chain teams to ensure successful design transfer and production scale-up.
• Identify opportunities for intellectual property (patents, design disclosures) and contribute to the IP portfolio.
• Participate in customer technical discussions, design reviews, and problem-solving sessions (requires travel).
• Apply business and project management skills to prioritize work, manage timelines, and communicate status and risks to stakeholders.
• Mentor junior engineers and contribute to continuous improvement of design processes and best practices.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering (Master’s or MBA strongly preferred).
• 5+ years of progressive mechanical design experience in product development (automotive, medical devices, or precision electromechanical systems preferred).
• Proven track record of designing complex mechanisms and assemblies (e.g., kinematic systems, moving parts, self-cleaning or adaptive features, fuel/access doors, camera or sensor housings, etc.).
• Hands-on experience with CAD modeling, GD&T, tolerance stack-up analysis, and FEA.
• Experience generating patents or technical publications/research disclosures.
• Strong understanding of manufacturing processes (injection molding, machining, stamping, assembly) and DFM/DFA principles.
• Familiarity with regulated environments (medical device quality systems preferred; automotive experience transferable).
• Excellent problem-solving, communication, and cross-functional collaboration skills.
• Ability and willingness to travel 25–35% of the time.
• Authorization to work in the United States.

Preferred Qualifications

• Experience in medical device or healthcare contract manufacturing (e.g., Jabil Healthcare or similar).
• Prior work at a Fortune 500 company in product engineering.
• Knowledge of camera/sensor cleaning systems, vehicle or equipment access mechanisms, or similar precision motion systems.
• French language skills a plus.
• Project management experience or formal business training (MBA).

What We Offer

• Fully remote work arrangement with a New York head office for collaboration and occasional in-person meetings.
• Competitive base salary + bonus potential.
• Comprehensive benefits package.
• Opportunity to work on meaningful healthcare products that improve patient outcomes.
• Professional development support and exposure to both technical and commercial aspects of product development.
• This role is ideal for an engineer who combines deep mechanical design expertise with business mindset and thrives in a remote setting while remaining connected to customers and manufacturing operations through targeted travel.