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 closely with surgeons and all other functions of the company to ensure high quality and on-time product introductions.
- Obtain market feedback from 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 (DHF) for each project
- Manage 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
- Design and develop instruments and implants in the areas of biomaterials, tissue engineering, and drug delivery
- Design experiments, analyze data, troubleshoot protocols, document results, and communicate findings clearly with the team
- Perform design verification and validation activities to ensure designs meet specifications
- Partner 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.
- Collaborate with the operations department to setup manufacturing
- Participate 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
- Adhere 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
- Represent 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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
- Minimum five years of engineering experience, preferably in the medical device field
- Master's degree in biomedical engineering, or similar life sciences area of study
- Strong hands-on experience developing biomaterials, including hydrogels, scaffolds, coatings, porous materials, or related tissue-interfacing materials
- Experience with in vivo testing of biomaterials in applications such as wound healing, wound dressings, tissue regeneration, bone regeneration, soft tissue repair, implantable materials, injectable materials, drug delivery systems, or regenerative medicine
- Ability to work in fast paced environment; Multi-tasking abilities required for successful job completion
- 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
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus