At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
Position Summary:
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.
Essential Functions:
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.
Qualifications:
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
Proven leader of people with strong self-starting skills
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
Proficient in preparation of reports and budgets
Proficient in Microsoft Office
Physical Demands:
The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
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
Our Values:
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.
Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity:
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
