Associate Project Engineer, Sustaining
Globus Medical
Summary
The Associate Project Engineer - Sustaining in the Product Development team plays a pivotal role in supporting the ongoing success and optimization of our commercial product portfolio. This position bridges engineering, quality, clinical, and manufacturing functions to ensure that products on the market perform to the highest standards of safety, usability, and efficiency. You will contribute to sustaining engineering efforts, evaluate field performance, and implement improvements that directly impact patient outcomes.
Job description
Key Responsibilities
- Design and implement product line extensions, working closely with the 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 directly 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.
- Conduct complaint evaluations, identify root causes, and implement corrective actions in collaboration 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.
Required Qualifications
- 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) for mechanical design and documentation.
- 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 thrive in both engineering and clinical environments, including operating rooms and cadaver labs.
- Familiarity with risk management principles and design control processes in regulated industries.
Preferred Qualifications
- 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.
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
- Strong analytical and problem-solving skills with attention to detail
- Effective verbal and written communication skills for cross-functional collaboration
- Ability to thrive in both engineering and clinical environments, including operating rooms and cadaver labs
- Familiarity with risk management principles and design control processes in regulated industries
Company overview
Globus Medical, Inc. is a leading publicly traded orthopedic medical device company headquartered in Audubon, Pennsylvania, founded in 2003. The company specializes in the design, development, and commercialization of innovative musculoskeletal solutions that enable surgeons to promote healing in patients with musculoskeletal disorders. Globus Medical has established itself as the fastest growing company in the history of orthopedics through its single-minded focus on advancing surgical technologies. The company's comprehensive product portfolio includes spinal implants, trauma solutions, artificial joints, and the revolutionary ExcelsiusGPS surgical robotic system for spine surgery. Their robotic navigation technology provides sub-millimeter accuracy for transpedicular drilling and screw placement procedures. Globus Medical also offers advanced surgical planning software and registry solutions like SpineTRACK and OrthoTRACK for comprehensive treatment outcomes data collection. The company's mission is to utilize superior engineering and technology to achieve pain-free, active lives for all patients, driving significant technological advancements across a complete suite of orthopedic products.