Project Engineer (Biomaterials) Globus Medical

Description
The Project Engineer-Biomaterials will be responsible for all engineering functions of their product lines. This includes bringing a product from concept through design, prototyping, testing, verification and validation, manufacturing, FDA approval, product introduction and post-introduction monitoring. This individual will work with spine surgeons and others to ensure high-quality and on-time product introductions. This team player must have experience with multi-tasking in a high-energy, fast-paced environment.

Responsibilities

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 (DHFs).

3. Manage all aspects of the 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. Work with in-house prototype shop and outside vendors for rapid prototyping and evaluation

6. Perform design verification and validation activities to ensure designs meet specifications

7. Work with marketing and product managers to develop forecasts and market plans

8. Assist in the writing of regulatory applications to the FDA and other regulatory bodies

9. Work with the operations department to setup manufacturing and/or purchasing as appropriate for each project

10. Assist in product introductions through sales training, customer calls/visits, etc.

11. Research market and competition on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered


Qualifications
1. Three to seven years of biomedical/mechanical design engineering experience, preferably in the medical device field.

2. Expertise in Pro/E software or similar is required.

3. Excellent communication skills required.

4. Working knowledge of Microsoft Office, especially Microsoft Excel.

5. Strong self-starting skills.

6. Well-organized, detail-oriented team player capable of working under a deadline

7. Ability to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers.

8. Bachelor's degree in Mechanical Engineering or Biomedical Engineering is required. 4 years of additional design experience may suffice in lieu of a degree.

Location:	Valley Forge Business Center 2560 General Armistead Avenue Audubon, PA 19403 United States