MedTech Mechanical Engineer

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 Engineering, Risk Management.






Show more Show less