Senior Mechanical Engineer (Medical Devices)
Marlborough, Massachusetts, United States of America
Contract
3 days ago
$120,000 USD
Key skills
PrototypingCollaboration
About this role
Location: Marlborough, MA
Salary: $120,000.00 USD Annually - $125,000.00 USD Annually
Description:
We are seeking a Senior Opto-Mechanical Engineer II to lead the development of advanced medical devices and subsystems. This role requires strong experience in opto-mechanical systems, regulatory compliance, and cross-functional collaboration across the full product lifecycle from concept through manufacturing transfer.
Responsibilities
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.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Salary: $120,000.00 USD Annually - $125,000.00 USD Annually
Description:
We are seeking a Senior Opto-Mechanical Engineer II to lead the development of advanced medical devices and subsystems. This role requires strong experience in opto-mechanical systems, regulatory compliance, and cross-functional collaboration across the full product lifecycle from concept through manufacturing transfer.
Responsibilities
- 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.
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.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!