About this role
Job Summary
We are seeking a Senior Design Engineer with a strong background in medical device product design and development. The ideal candidate will lead the design of innovative medical devices from concept through commercialization, ensuring compliance with regulatory standards while collaborating with cross-functional engineering and manufacturing teams.
Key Responsibilities
• Design and develop medical device components and assemblies from concept to production.
• Create and review 3D CAD models, detailed drawings, and engineering documentation.
• Perform design verification, validation, tolerance analysis, and risk assessments.
• Support prototype development, testing, design iterations, and product improvements.
• Collaborate with Manufacturing, Quality, Regulatory, and R&D teams throughout the product lifecycle.
• Participate in design reviews, DFMEA, root cause investigations, and design change activities.
• Ensure compliance with FDA, ISO 13485, IEC 60601, and applicable medical device regulations.
• Support manufacturing transfer, process development, and product launch activities.
Required Qualifications
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 7+ years of medical device product design and development experience.
• Strong proficiency with SolidWorks, Creo, or similar 3D CAD software.
• Experience with GD&T, DFMEA, Design Controls, Verification & Validation (V&V), and Design for Manufacturability (DFM).
• Knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and medical device design control requirements.
• Experience working with cross-functional teams in a regulated medical device environment.
• Excellent analytical, problem-solving, and communication skills.
Preferred Qualifications
• Experience with Class II or Class III medical devices.
• Familiarity with injection molding, machining, plastics, and metal components.
• Experience supporting regulatory submissions and product commercialization.