Project Engineer

Globus Medical•Audubon, PA

About The Position

Globus Medical is seeking a dynamic, detail-oriented Project Engineer to join its Product Development team. The role drives projects from concept through commercialization and supports mature products throughout their lifecycle. The Project Engineer uses engineering skills and customer and cross-functional collaboration to deliver innovative solutions for surgical instruments and implants. The role includes leading design and development using CAD software, managing project plans and FDA-compliant Design History Files, completing design verification and validation, and supporting regulatory submissions. The Project Engineer also gathers feedback from surgeons and other customers, participates in product introductions and surgical case support, and contributes to product lifecycle management, including quality, supply chain, cost, design, and documentation improvements. The employee is expected to follow the company’s codes of conduct and policies, comply with applicable laws and regulations, complete required compliance training, and represent the company professionally and ethically. Reasonable accommodations may be made for individuals with disabilities to perform essential functions.

Requirements

Bachelor’s degree in Mechanical Engineering, Bioengineering, Biomedical Engineering, or a similar field.
At least 3 years of experience in mechanical design engineering.
Proficiency with CREO and/or SolidWorks for design and drafting.
Proficiency with CAD software for mechanical design and documentation.
Proficiency with Microsoft Excel, PowerPoint, and Project for data analysis, presentations, and project tracking.
Well-organized, detail-oriented, and able to work as a team player in a deadline-driven environment.
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.

Nice To Haves

Medical device experience is strongly preferred.

Responsibilities

Lead the design and development of surgical instruments and implants using CAD software such as CREO.
Create and maintain project plans and FDA-compliant Design History Files for each project.
Manage assigned projects to ensure timely completion while complying with Globus Medical’s quality system and applicable regulatory requirements.
Perform design verification and validation activities to ensure designs meet specifications.
Coordinate with in-house prototype shops and external vendors for rapid prototyping and evaluation.
Assist in writing regulatory applications for the FDA and other regulatory bodies.
Obtain market feedback from surgeons and other customers to define functional and design specifications for new products.
Participate in product introductions through sales training, customer calls and visits, and operating-room case support; gather real-time feedback and identify clinical opportunities for improvement.
Monitor products after introduction, address customer change requests, and support customer satisfaction.
Collaborate with marketing and product managers on forecasts and market plans.
Partner with operations to establish manufacturing and purchasing arrangements as appropriate for each project.
Research the industry and direct competitors to support cutting-edge technology in markets entered by the company.
Support lifecycle management of commercialized products by addressing quality issues, supply-chain changes, and cost-improvement initiatives.
Drive design updates and documentation revisions to maintain compliance and product performance.
Work with Quality, Regulatory, Manufacturing, and Supply Chain teams to evaluate and implement engineering changes.
Identify and communicate improvement opportunities based on customer feedback, internal testing, or supplier input.
Follow the company Code of Conduct, AdvaMed Code, MedTech Code, and other company policies.
Comply with applicable governmental laws, rules, and regulations in the United States and internationally, including completing introductory and annual training.
Represent the company professionally and uphold ethical business practices and socially responsible conduct.