Project Engineer Globus Medical
The Project Engineer will be responsible for all engineering functions of their product lines. This includes bringing a product from idea/concept through design, prototyping, development testing,design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This individual will work with spine surgeons and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy fast paced environment.
1. Obtain market feedback from spine surgeons and other customers to determine functional and design specifications for new product development
2. Create and maintain project plans and FDA complaint Design history Files (DHF) for eachproject.
3. Management of all aspects of project to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies
4. Design and develop instruments and implants using Pro/E software.
5. Working with in-house prototype shop and outside vendors for rapid prototyping and evaluation
6. Performing design verification and validation activities to ensure designs meet specifications
7. Working with marketing and product managers to develop forecasts and market plans
8. Assisting in the writing of regulatory applications to the FDA and other regulatory bodies
9. Working with the operations department to setup manufacturing and/or purchasing as appropriate for each project
10. Assisting in product introductions through sales training, customer calls/visits, etc.
11. Maintaining diligent post introduction monitoring to address and customer requests for changes
12. Researching market and competition on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
1. Three to seven years of mechanical design engineering experience preferably in the medical device field
2. Proficiency in Pro/E software for design and drafting required
3. Proven leader of people with strong self-starting skills
4. Ability to work in fast paced environment. Multi-tasking abilities required for successful job completion
5. Well organized, detail oriented and team player capable of working in a deadline dictated environment
6. Ability to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers
7. Proficient in preparation of reports and budgets
8. Bachelor's degree in Mechanical Engineering required. 4 years of additional design experience may suffice in lieu of a degree.
9. Working knowledge of Microsoft Office
||Valley Forge Business Center |
2560 General Armistead Avenue
Audubon, PA 19403