Associate Project Engineer, Sustaining

Globus Medical•Audubon, PA

16h

About The Position

The Associate Project Engineer - Sustaining in the Product Development team supports the ongoing success and optimization of Globus Medical’s commercial product portfolio. The role bridges engineering, quality, clinical, and manufacturing functions to help ensure products on the market meet high standards of safety, usability, and efficiency. The engineer contributes to sustaining engineering, evaluates field performance, and implements improvements that affect patient outcomes. The position designs product line extensions, supports manufacturing improvements and resolution of manufacturing challenges, and provides technical support in clinical settings, including cadaver labs and operating rooms. It also contributes to product scrap analysis, complaint evaluation, root-cause investigation, corrective actions, risk analysis, and post-market safety reporting in accordance with global regulatory standards. The employee is expected to follow the company’s Code of Conduct, applicable industry codes, company policies, and governmental laws and regulations; complete required compliance training; and maintain professional, ethical, and socially responsible conduct in interactions with employees, customers, suppliers, and other third parties. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
0–2 years of experience in product development or sustaining engineering within the medical device industry.
Proficiency with CAD software; CREO or SolidWorks preferred.
Proficiency with Microsoft Excel, PowerPoint, and Project for data analysis, presentations, and project tracking.
Strong analytical and problem-solving skills, with attention to detail.
Effective verbal and written communication skills for cross-functional collaboration.
Ability to work in engineering and clinical environments, including operating rooms and cadaver labs.
Familiarity with risk management principles and design control processes in regulated industries.

Nice To Haves

Internship or co-op experience in a regulated industry, ideally medical devices.
Exposure to post-market surveillance activities or complaint handling systems.
Understanding of ISO 13485, FDA 21 CFR Part 820, or EU MDR regulations.

Responsibilities

Design and implement product line extensions in collaboration with R&D, clinical, and regulatory teams.
Champion Design for Manufacturing (DFM) improvements across launched product lines to optimize cost, reliability, and manufacturability.
Resolve manufacturing challenges through vendor coordination and iterative design updates.
Provide technical support during cadaver labs and customer engagement meetings to validate and refine device performance.
Support surgical cases in the operating room, working with surgeons to gather real-time feedback and identify clinical opportunities for improvement.
Perform product scrap analysis and coordinate remediation strategies to improve yield and performance.
Evaluate complaints, identify root causes, and implement corrective actions with cross-functional teams.
Lead and contribute to Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR) in compliance with global regulatory standards.
Drive risk analyses to assess and mitigate design and process risks.
Follow the company Code of Conduct, AdvaMed Code, MedTech Code, other company policies, and applicable governmental laws and regulations; complete introductory and annual compliance training.
Represent the company professionally and uphold ethical business practices and socially responsible conduct in interactions with employees, customers, suppliers, and other third parties.