Senior Project Engineer- Biomaterials Globus Medical
THIS JOB HAS EXPIRED
Senior Project Engineer- Biomaterials
The Senior Project Engineer, Biomaterials 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.
Work as part of a product development team to bring biologic products from concept to full market launch in 12 months or less
Obtain market feedback from spine surgeons and other customers to determine functional and design specifications for new product development
Design and develop implants, packaging drawings, BOMs, and other applicable resources using Pro/E software.
Develop an experimental design and prototypes for rapid evaluation of products to meet design criteria
Performing design verification and validation activities to ensure designs meet specifications
Develop manufacturing processes for mass production, packaging, and sterilization of products developed in design stage
Create and maintain project plans and FDA complaint Design history Files (DHF) for each project.
Manage all aspects of project to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies
Work 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
Assist in product introductions through sales training, customer calls/visits, etc.
Maintain diligent post introduction monitoring to address and customer requests for changes
Research market and competition on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
Minimum five years of product development experience, preferably in development of biologic products designed to enhance bone healing
Experience in development of prototypes of implantable biomaterials products including tissue, allograft, stem cells, proteins, cell concentration, medical grade synthetics, etc.
Experience developing manufacturing methods for all of the above
Familiarity with biocompatibility requirements per ISO-10993
Experience in product validations through FDA-mandated animal testing
Ability to present complex ideas in a simple manner for marketing and training tools
Ability to work in fast paced environment. Multi-tasking abilities required for successful job completion
Proven leader of people with strong self-starting skills
Well organized, detail oriented and team player capable of working in a deadline dictated environment
Ability to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers
Bachelor's degree in applicable Engineering fields required (biological, tissue, biomaterials, chemical). Masters level preferred.
Working knowledge of Microsoft Office
||Valley Forge Business Center |
2560 General Armistead Avenue
Audubon, PA 19403
THIS JOB HAS EXPIRED