Judge Group, Inc.
Judge Group, Inc.

Senior Mechanical Engineer (Medical Devices)

Marlborough, MA, US • Posted 1 day ago • Updated 2 hours ago
Contract Independent
On-site
USD $120,000.00 - 125,000.00 per year
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Job Details

Skills

  • Mergers and Acquisitions
  • Verification And Validation
  • Electronics Manufacturing
  • Product Development
  • Intellectual Property
  • Manufacturing
  • Cost Reduction
  • Regulatory Compliance
  • Customer Engagement
  • Technical Writing
  • Medical Devices
  • FOCUS
  • 3D CAD
  • SolidWorks
  • Data Management
  • PDM
  • Microsoft Office
  • Microsoft Excel
  • Microsoft PowerPoint
  • Microsoft Visio
  • Collaboration
  • Instrumentation
  • ISO 13485
  • Team Leadership
  • Systems Design
  • Drawing
  • Thermal Management
  • Adobe AIR
  • System Integration
  • Interfaces
  • Mechanical Engineering
  • Rapid Prototyping
  • Management
  • Negotiations
  • Analytical Skill
  • Attention To Detail
  • Project Implementation
  • Budget
  • Privacy
  • Marketing

Summary

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
  • 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.
Minimum Qualifications
  • 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.
Preferred Qualifications
  • 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.

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!
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: cxjudgpa
  • Position Id: 1134652
  • Posted 1 day ago

Company Info

About Judge Group, Inc.

The Judge Group, is a leading professional services firm specializing in talent, technology, and learning solutions. We consult, staff, train, and solve. Through our work we make people and organizations better.

Our services are successfully delivered through a network of more than 30 offices across the United States, Canada, and India. The Judge Group is proud to partner with the best and brightest companies in business today, including over 60 of the Fortune 100. We serve organizations in financial services, healthcare, life sciences, insurance, government (including aerospace and defense), manufacturing, and technology and telecommunications.

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