Senior Mechanical Engineer - Medical Device

Here is a streamlined, more punchy version of the job ad with a significantly condensed benefits section:Senior Mechanical Engineer - Medical DevicesLocation: Wilmington, MASalary Range: $105,000 - $135,000 / year (DOE)Employment Type: Full-timeMust-HavesExperience: 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 RoleWe 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 ResponsibilitiesDesign & 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.BenefitsRetirement: 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.