Mechanical Engineer(Onsite)

Mechanical Engineer

Boston MA

Job Description:

We are looking for a skilled Mechanical Engineer with strong Medical Device industry experience to support the design, development, and improvement of innovative medical products. The ideal candidate will have hands-on experience in mechanical design, product development, prototyping, and verification/validation activities within a regulated medical device environment.

Required Qualifications & Experience:

5+ years of experience as a Mechanical Engineer in the Medical Device / MedTech industry

Strong experience designing and developing medical devices, surgical instruments, diagnostic equipment, or electromechanical medical systems

Experience working through the full medical device product development lifecycle from concept to production

Hands-on experience with mechanical design, 3D modeling, assemblies, and detailed drawings

Proficiency with CAD tools such as SolidWorks, Creo, CATIA, or similar

Strong knowledge of GD&T, tolerance stack-up analysis, and engineering drawings

Experience with Design Verification and Validation (DV/V) testing

Experience with Design Controls, Risk Management, and documentation for FDA-regulated products

Knowledge of ISO 13485 quality systems and medical device development processes

Experience with DFM/DFA, injection molding, plastics, machining, and manufacturing processes

Ability to perform root cause analysis, failure analysis, and corrective actions

Experience supporting ECO/ECN processes and product changes

Key Responsibilities:

Design, develop, and optimize mechanical components and assemblies for medical devices

Create and maintain engineering drawings, specifications, and design documentation

Develop prototypes and support design iterations based on testing results

Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Suppliers

Support verification testing, validation activities, and product releases

Identify design risks and provide engineering solutions

Participate in product improvements, cost reduction initiatives, and sustaining engineering activities

Ensure designs meet regulatory, safety, and performance requirements

Preferred Experience:

Experience with Class II / Class III medical devices

Experience with FDA submissions, DHF (Design History File), DMR documentation

Experience with biocompatible materials and medical-grade plastics

Experience with disposable medical devices, implants, robotics, wearables, or surgical products

Education:

Bachelor s or Master s degree in Mechanical Engineering, Biomedical Engineering, or related field

Must-Have Keywords:

Medical Device, MedTech, Mechanical Design, Product Development, FDA, ISO 13485, Design Controls, DV/V, SolidWorks, Creo, GD&T, DFM, FMEA, Prototyping, Injection Molding, Sustaining