Associate Project Engineer, Medical Devices
Overview
You will own the full engineering lifecycle for Excelsius Cranial hardware and instrumentation, from concept through FDA approval and post-market monitoring. You will work with surgeons and cross-functional teams to deliver high-quality, on-time product introductions in a demanding medical device environment. This role offers direct exposure to CAD design, FDA regulatory processes, and manufacturing support. You will be the engineering voice bridging clinical needs and product execution.
What You'll Do9
- 1Define functional and design specifications by gathering market feedback from surgeons and customers.
- 2Manage assigned projects from concept to completion, ensuring compliance with Globus quality systems and regulatory bodies.
- 3Create product requirements, specifications, and test documents for Excelsius Cranial hardware.
- 4Develop manufacturing test fixtures and documentation to support production launch.
- 5Diagnose quality issues with manufacturing and external customers, identifying root causes and implementing corrective plans.
- 6Execute design verification and validation activities to confirm designs meet specifications.
- 7Define and implement inspection procedures for incoming parts.
- 8Support product introductions through sales training and customer visits.
- 9Address sustaining activities including complaints, CAPAs, and NCMRs.
Requirements9
- 10-2 years of mechanical engineering experience; medical device industry experience preferred.
- 2Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or similar program (or 4+ years of design experience in lieu).
- 3Proficiency in CAD software; CREO Parametric preferred, also Pro/E and SolidWorks.
- 4Strong aptitude for mechanical systems, materials, and manufacturing methods.
- 5Familiarity with industry practices and procedures for medical device development.
- 6Ability to work independently and contribute to small teams.
- 7Excellent oral and written communication skills.
- 8Proficient in Microsoft Office applications.
- 9Ability to travel up to 5% and attend surgeries or labs.
Salary Insight
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