MedTech Project Engineer — Design, Validation & FDA

Branch Medical Group; Lower Providence Township (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

Globus Medical is seeking a mechanical design engineer to develop instruments and implants for the medical device market. You will lead project plans, maintain DHFs, and work with prototyping shops and vendors to rapidly evaluate concepts while ensuring compliance with FDA and quality systems.

Ideal candidates have 3–7 years in mechanical design for medical devices, a relevant degree, and strong skills in Pro/E, GD&T, and risk analysis. Occasional lab or surgery attendance may be required.

Qualifications

• Three to seven years’ experience in mechanical design engineering; Medical device experience strongly preferred.
• Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering or a similar degree.
• Proficiency in Pro/E software or similar CAD software for design and drafting; knowledge of GD&T.
• Knowledge of risk analysis techniques.
• Strong verbal and written communication skills.
• Well organized, detail oriented, and team player capable of working in a deadline driven environment.
• Experience in preparing reports and managing project budgets.
• Strong knowledge of Microsoft Office.
• Ability to attend surgeries and/or labs.

Responsibilities

• Obtaining market feedback from surgeons and other customers to determine functional and design specifications for new product development
• Creating and maintaining project plans and FDA compliant Design history Files (DHF) for each project
• Managing 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
• Designing and developing instruments and implants using Pro/E software
• Working with in-house prototype shop and outside vendors for rapid prototyping and evaluation
• Performing design verification and validation activities to ensure designs meet specifications
• Collaborating with marketing and product managers to develop forecasts and market plans
• Assisting in the writing of regulatory applications to the FDA and other regulatory bodies
• Coordination with the operations department to setup manufacturing and/or purchasing as appropriate for each project
• Participating in product introductions through sales training, customer calls/visits, etc.
• Maintaining diligent post introduction monitoring to address and customer requests for changes
• Researching industry and direct competitors on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
• Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure 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
• Representing the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus

Skills

Mechanical design

Medical devices

Pro/E / CAD

GD&T

Verbal & written comms

Project budgeting

Attend surgeries/labs

Education

Bachelor's degree in Mechanical Engineering

Tools

Pro/E

CAD software

Job description

Globus Medical is seeking a mechanical design engineer to develop instruments and implants for the medical device market. You will lead project plans, maintain DHFs, and work with prototyping shops and vendors to rapidly evaluate concepts while ensuring compliance with FDA and quality systems.

Ideal candidates have 3–7 years in mechanical design for medical devices, a relevant degree, and strong skills in Pro/E, GD&T, and risk analysis. Occasional lab or surgery attendance may be required.