Senior Mechanical Engineer (Medical Devices)

• Lead the development of complex medical devices and subsystems across all product lifecycle phases, including design input, development, verification and validation, and transfer to manufacturing.
• Translate system-level requirements into detailed mechanical and opto-mechanical designs aligned with product performance and regulatory standards.
• Partner with cross-functional teams, including systems, electronics, manufacturing, and quality, to ensure integrated product development.
• Contribute to intellectual property development by creating innovative technical solutions that improve product performance, functionality, reliability, and cost.
• Define and maintain product specifications in collaboration with marketing, customers, and internal stakeholders.
• Support product transfer activities to customers, distributors, and manufacturing sites, including investigation of customer feedback and complaints.
• Drive cost reduction initiatives while maintaining product quality and compliance with global regulatory requirements.
• Ensure designs meet applicable standards, including FDA regulations, ISO 13485, CE marking, and other regional requirements.
• Develop and maintain design history files and technical documentation required for regulatory submissions and product commercialization.
• Manage project timelines, budgets, and deliverables while coordinating internal teams, external partners, and suppliers.

• Bachelor's degree in Mechanical Engineering; Master's degree preferred.
• 10+ years of mechanical design engineering experience in medical devices, with a focus on laser or optical systems.
• Demonstrated experience leading engineering projects and cross-functional teams.
• Proficiency with 3D CAD tools, preferably SOLIDWORKS, including Product Data Management (PDM) systems.
• Strong understanding of engineering fundamentals for component and mechanism design.
• Experience with Microsoft Office tools, including Word, Excel, PowerPoint, Project, and Visio.
• Ability to travel up to 20% to support collaboration with domestic partners and regional facilities.

• Experience designing light-based medical instrumentation and products in an ISO 13485 and FDA-regulated environment.
• 5+ years in a senior or lead engineering role responsible for technical project oversight and team coordination.
• Expertise in opto-mechanical system design, including optical alignment, stability, packaging, and tolerance analysis.
• Knowledge of optical materials, coatings, and technical drawing practices.
• Experience with thermal management solutions such as air cooling, fluid cooling, and thermoelectric cooling (TEC).
• Familiarity with device packaging, system integration, automation, and interfaces between mechanical, optical, and electronic systems.
• Proven track record in rapid prototyping and supporting pre-clinical and clinical development activities.
• Experience managing suppliers and development partners, including negotiating technical requirements and specifications.

Additional Information

The ideal candidate is a highly motivated engineer with strong analytical skills, attention to detail, and the ability to work effectively in a fast-paced, regulated environment. This role requires balancing technical depth with project execution, ensuring delivery within defined timelines and budgets.

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