Project Engineer- Biomaterials 9/19/2017
Globus Medical, Inc.
JOB DESCRIPTIONAPPLY Globus Medical, a leader in providing musculoskeletal solutions, has an exciting opportunity for a Project Engineer in the Biomaterials division. This individual will work closely with a highly trained team and utilize the in-house capabilities to study bone biology. The project engineer will lead the development functions of their product lines to deliver best in class products that benefit patient outcomes. 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 closely with spine surgeons and other clinical personnel to ensure competitive high-quality and on-time product introductions. This team player must have experience with multi-tasking in a high-energy, fast-paced environment.
* Develop cell based Biomaterials for orthopedic applications.
* Design pre-clinical studies and work with CRO s in executing the studies in a timely manner.
* Obtain market feedback from spine surgeons and other customers to determine functional and design specifications for new product development
* Create and maintain project plans and FDA complaint Design History Files (DHFs)
* 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
* Perform design verification and validation activities to ensure designs meet specifications
* Work with marketing and product managers to develop forecasts and market plans
* Assist in the writing of regulatory applications to the FDA and other regulatory bodies
* Work with the operations department to setup manufacturing and/or purchasing as appropriate for each project
* Assist in product introductions through sales training, customer calls/visits, etc.
* Research market and competition on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
* Master s in Biomedical Engineering M.S with 3+ years experience in medical device.
* Expertise in mammalian cell culture is required. Mesenchymal stem cell experience is preferred.
* Proficient in in vitro studies to understand mesenchymal stem cell interaction on various biomaterials.
* Experience in bone biology, histomorphometry and micro-CT preferred.
* Experience in recombinant protein technology preferred.
* Strong skills in performing in vitro assays and analytical testing of biomaterials.
* Excellent communication skills required.
* Working knowledge of Microsoft Office, especially Microsoft Excel.
* Strong self-starting skills.
* Well-organized, detail-oriented team player capable of working under a deadline
* Ability to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers.
Globus Medical is an Equal Opportunity Employer. EOE M/F/D/V