Senior Mechanical Engineer - Medical Device - Medical Devices
Senior Mechanical Engineer - Medical Device - Medical Devices
Lead medical device design projects from concept through verification, with SolidWorks, FDA Design Controls, ISO 13485/14971, IEC 60601, DFX, prototyping, and testing. Requires 5+ years, a BS in Mechanical Engineering or related field, and U.S. work authorization without sponsorship.
Here is a streamlined, more punchy version of the job ad with a significantly condensed benefits section:
Senior Mechanical Engineer - Medical Devices
Location: Wilmington, MA
Salary Range: $105,000 - $135,000 / year (DOE)
Employment Type: Full-time
Must-Haves
Experience: 5+ years of medical device product development and mechanical design.
Education: BS in Mechanical Engineering or related field.
CAD: High proficiency in SolidWorks (2D/3D, GD&T, tolerance analysis).
Standards & Regulatory: Working knowledge of FDA Design Controls (21 CFR Part 820), ISO 13485, ISO 14971, and IEC 60601.
Domain: Experience in Cardiovascular, Neurology, Orthopedics, Women's Health, or Diabetes.
Hands-on Skills: DFX, rapid prototyping, precision design (injection molding, machining, 3D printing), and DHF/verification testing.
About the Role
We are seeking a Senior Mechanical Engineer to lead and execute medical device design projects from concept through verification. In this role, you will lead interdisciplinary engineering teams, manage client design reviews, and solve complex technical challenges to deliver life-changing medical technologies.
Key Responsibilities
Design & DFX: Create concepts for mechanisms and housings using injection molding, machining, laser cutting, and 3D printing.
Prototyping & Testing: Run iterative design cycles, FEA, root cause analysis, tolerance stackups, and formal verification testing.
DHF & Quality: Lead Design History File documentation, including risk management (xFMEA), design inputs/outputs, and test plans within a QMS.
Client & Team Leadership: Manage client communication on deliverables, collaborate across engineering disciplines, and mentor junior staff.
BD Support: Assist with project scoping and risk identification for new business opportunities.
For this position you must be currently authorized to work in the United States. We do not sponsor for this position.
Benefits
Retirement: 401(k) with a 3 percent automatic company contribution.
Health Insurance: 80 percent employer-covered medical premiums, plus comprehensive dental and vision options.
Time Off & Leave: Flexible time off, paid sick/bereavement leave, and 6 weeks fully paid parental leave.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. Our hiring process includes AI screening for keywords and minimum qualifications, and a virtual recruiter as part of the application process. A human recruiter reviews all results. Click here for details on our virtual recruiter . Everforth CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. Everforth CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. Individuals needing special assistance or an accommodation while seeking employment can contact a member of our Human Resources team at Benefits@CyberCoders.com to make arrangements.
Salary
$105000 - $135000 USD per year