Project Engineer

globusmedical; Lower Providence Township (PA); On-site; USD 85,000 - 110,000; Full time

Job summary

Globus Medical is seeking a dynamic Project Engineer to join the Product Development Trauma team. This role drives projects from concept to commercialization and supports mature products throughout their lifecycle, collaborating with cross-functional teams and surgeons to deliver innovative and safe surgical instruments and implants.

You will lead design and development using CREO/SolidWorks, create DHF files, support regulatory submissions, perform DV/AV, and help transition products to

Qualifications

• Bachelor's degree in engineering or related field.
• 3+ years of mechanical design experience in medical devices preferred.
• Strong CAD skills (CREO/SolidWorks) and design documentation.

Responsibilities

• Lead design and development of surgical instruments and implants.
• Create and maintain FDA DHF for each project.
• Manage projects to meet timelines while ensuring compliance with quality systems and regulations.
• Perform design verification and validation activities.
• Collaborate with internal prototype shops and external vendors for rapid prototyping.

Skills

Mechanical design

Medical device experience

Cross-functional collaboration

Analytical thinking

Communication skills

Education

Bachelor's Degree in Mechanical Engineering

Tools

CREO

SolidWorks

CAD drafting

Microsoft Project

Job description

PROJECT ENGINEER

We are seeking a dynamic and detail-oriented Project Engineer to join our Product Development Trauma team. This role is pivotal in driving projects from concept through commercialization and in supporting mature products throughout their lifecycle. The ideal candidate will possess strong engineering skills and a passion for engaging with customers and cross-functional teams to deliver innovative and sustainable solutions.

Essential Functions

• Product Development: Lead the design and development of surgical instruments and implants using CAD software (CREO).
• Create and maintain project plans and FDA-compliant Design History Files (DHF) for each project.
• Manages all aspects of assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies.
• Perform design verification and validation activities to ensure designs meet specifications.
• Partner with in-house prototype shops and external vendors for rapid prototyping and evaluation.
• Assist in writing regulatory applications to the FDA and other regulatory bodies.
• Obtain market feedback from surgeons and other customers to determine functional and design specifications for new product development.
• Participate in product introductions through sales training, customer calls/visits, and support surgical cases in the operating room, working directly with surgeons to gather real-time feedback and identify clinical opportunities for improvement.
• Maintain diligent post-introduction monitoring to address customer requests for changes and ensure customer satisfaction.
• Collaborate with marketing and product managers to develop forecasts and market plans.
• Partner with the operations department to set up manufacturing and/or purchasing as appropriate for each project.
• Research industry and direct competitors on an ongoing basis to ensure that Globus has cutting-edge technology in all markets entered.
• Supports lifecycle management of commercialized products by addressing quality issues, supply chain changes, and cost improvement initiatives.
• Drive design updates and documentation revisions as needed to maintain compliance and product performance.
• Collaborate with Quality, Regulatory, Manufacturing, and Supply Chain teams to evaluate and implement engineering changes.
• Proactively identify and communicate improvement opportunities based on customer feedback, internal testing, or supplier input.

Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications

• Bachelor's Degree in Mechanical Engineering, Bioengineering, Biomedical Engineering, or a similar field.
• 3+ years of experience in mechanical design engineering; medical device experience strongly preferred.
• Proficiency in CREO and/or SolidWorks software for design and drafting.
• 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.
• Well-organized, detail-oriented, and a team player capable of working 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 thrive in both engineering and clinical environments, including operating rooms and cadaver labs.

Physical Demands

• Required to sit; climb or balance; and stoop, kneel, crouch, or crawl.
• Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required inc