Biomaterials Project Engineer
At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them.
Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that speed is critical because life cannot wait. Join us!
The Biomaterials Project Engineer will be responsible for all engineering functions of their product lines, which may include stem cell-based therapies and other biologic products. 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.
The responsibilities of the position include, but are not limited to, the following:
- Developing biomaterials for use in orthopedic applications and other therapeutic applications including cell therapy
- Developing protocols for in vitro and in vivo evaluation of biocompatibility and efficacy
- Performing design verification and validation activities to ensure designs meet specifications
- Obtaining market feedback from spine surgeons and other customers to determine functional and design specifications for new product development
- Creating and maintaining project plans and Design History Files (DHF) for each project
- Managing all aspects of project to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies
- Working with the operations department to setup manufacturing and/or purchasing as appropriate for each project
- Assisting with product introductions through sales training, customer calls/visits, etc.
- Maintaining diligent post introduction monitoring to address and customer requests for changes
- Researching market and competition on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
- Adhering 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
- Representing 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
In order to be qualified for this role, you must possess the following:
- MS in a scientific related field and 3-5 years’ experience; PhD degree with 2+ years’ experience preferred
- Experience in stem cell research and/or stem cell therapy product development
- Deep understanding with methods and techniques of cell culture
- Good knowledge of cell characterization techniques, including flow and cytometry and immunohistochemistry
- Basic understanding of cell manufacturing methods and requirements
- Understanding of cell therapy process development
- Relevant experience in the biopharmaceutical industry
- Demonstrated superior oral and written communication skills and the ability to communicate complex issues in a succinct and logical manner
- Demonstrated ability to generate innovative solutions to complex problems and effectively work with and communicate to key stakeholders.
- Ability to travel 10-15%
- Will be required to attend surgeries and/or labs
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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.