Senior Mechanical Engineer, Medical Devices
Overview
Join the R&D team at Globus Medical to own mechanical design for intraoperative neuromonitoring systems used in complex spinal and cranial surgeries. You will lead both sustaining and next-generation NPI projects from concept through commercialization, collaborating with Regulatory, Quality, Supply Chain, and Manufacturing. Work directly with surgeons and OR staff to translate clinical needs into tangible solutions. This role offers the chance to shape products that improve patient outcomes and drive innovation in a fast-paced medical device environment.
What You'll Do9
- 1Lead mechanical design and development for NPI and sustaining projects, coordinating and managing engineering timelines.
- 2Create advanced mechanical designs using CAD and SolidWorks or rapid prototyping equipment for traditional, novel, and additive manufacturing methods.
- 3Apply design for manufacturing principles to ensure cost-effective and scalable production.
- 4Coordinate with suppliers and supply chain teams to manage production and commercialization, driving cost optimization.
- 5Maintain documentation for design control and regulatory compliance, including requirements, design specifications, FMEAs, and risk management.
- 6Collaborate with surgeons and OR staff to understand user needs and validate design intent through cadaver labs and surgeon education events.
- 7Oversee manufacturing partners to ensure complete, accurate, and timely delivery of clinical products.
- 8Participate in project planning, design reviews, and audits, and support design history file documentation.
- 9Adhere to company policies, the AdvaMed Code, and all applicable regulatory requirements, including ISO 13485 and IEC 60601.
Requirements8
- 15-7+ years of related experience in mechanical engineering, with a Bachelor's or advanced degree in Mechanical Engineering, Biomedical Engineering, or related field.
- 2Proficiency with CAD and SolidWorks (Pro/E, Creo, or SolidWorks), and Microsoft Office with strong technical writing skills.
- 3Strong knowledge of algebra, geometry, trigonometry, calculus, geometric tolerances, and tolerance analysis.
- 4Ability to read and interpret drawings, safety rules, and policy manuals.
- 5Solid understanding of manufacturing processes and design for manufacturing.
- 6Ability to interpret technical instructions in mathematical or diagram form and solve complex problems.
- 7Compliance with FDA and state regulations, including ISO 13485 and IEC 60601.
- 8Previous medical device experience required; spine or orthopedics preferred.
Salary Insight
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