Exciting career opportunity at the intersection of R&D and manufacturing in a growing medical device company. The Collagen Product/Process Engineer reports to the company’s top technical executive and offers significant responsibility and visibility. This innovative, well-funded start-up is developing bio-engineered surgical implants for the repair of ligaments and tendons, commonly injured during sports accidents. The inventor and founder, who is both an orthopedic surgeon and a biomaterials engineer, has developed a collagen-based implant that helps regenerate a patient’s own connective tissue and enables the body to heal itself. The procedure is minimally invasive and enables repair of ACL injuries without the need for a second, open surgery to harvest tissue for a transplant. The company has deep financial support from venture capital firms, the NIH, and the National Football League. It is managed by an experienced and successful team of medical industry veterans and has built strong relationships with orthopedists at leading teaching hospitals.
The Product/Process Engineer is responsible for establishing the process for production and transfer of collagen derived implants from the R&D lab to commercial manufacturing. You will have the lead role in establishing the lab and independently managing its day to day activities. The job scope also includes developing, verifying and validating new test methods to fully characterize the current material and process, and supporting innovation for future products. The creative individual in the position will have a key part in leveraging the company’s technology to proactively identify and develop new capabilities that could become commercial opportunities.
- Establish and improve implant the manufacturing process in the R&D Lab.
- Conduct and document Design V&V testing and support all Design Control activities for regulatory filings.
- Work closely with contract manufacturers to implement process improvements including yield and efficiency, product characterization, and in-process methods and controls.
- Drive further process & product development and support all innovation efforts.
- Support IP activities regarding product and process.
- BS or MS in Biomedical, Biomaterials or Chemical Engineering or related disciplines.
- Five – ten years of commercial experience processing collagen in a medical device R&D or pilot scale environment.
- Significant experience maintaining all aspects of an R&D lab.
- Demonstrable industrial experience developing, verifying and validating test methods in a Class 3 medical device environment.
- Experience testing, evaluating and optimizing tissue based medical devices.
- Background developing and documenting novel processes is a plus.
- Practical, results oriented mindset with a strong bias towards action and experimentation.
- Ability to ‘roll-up’ sleeves and do what it takes to get the job done as hands-on engineer.
- Ability to effectively prioritize and manage multiple tasks at the same time.
- Excellent verbal and writing skills, particularly when communicating results and findings to both technical and non-technical staff and partners.
- The ability to collaborate effectively across the organization, with CMs, and clinical partners.
- Must have strong attention to detail and be highly organized.
- Experience in surgery is a plus.