Sr. R&D Engineer

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Full-Time Eden Prairie, MN, US Salary Range: $100,000.00 To $120,000.00 Annually Location: On site: 6455 City West Pkwy Suite 100, Eden Prairie, MN 55344 Office hours: 8am-5pm Bonus: eligible for $13,000 annual bonus Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As Senior R&D Engineer , you will take full ownership of the technical execution for internal and contract product development projects. This is a high-impact role within the U.S. R&D organization, where you will be expected to champion innovation, navigate complex regulatory landscapes, and ensure the delivery of market-leading products through disciplined project leadership. Responsibilities Act as an SME, championing complex product development projects: researching, developing, and securing regulatory approval for new regenerative medicine products. Actively engage and collaborate on global cross-functional product development teams. Medical Device Design Control and Risk Management: Leveraging a high level of experience and skill, independently draft/author all typical design control documentation in accordance with relevant internal SOPs such as trace matrices, design verification plans and reports, risk documentation, design validation plans and reports, usability reports, and final product labeling (including IFUs). Identify and lead interactions with external vendors such as test labs (e.g., biocompatibility, animal study, and analytical) and suppliers. Independently author engineering reports and presentations as required to document and communicate findings. Apply deep knowledge and experience from across multiple clinical segments to research, develop, and formulate new products/prototypes, developing innovative solutions to satisfy customer needs. Independently design, execute, compile data, and draw conclusions for complex experimentation. Assist with clinical/user needs assessments. Assist with intellectual property searches and evaluations. Ensure compliance with regulatory and industry standards (FDA, MDD/MDR, ISO, ASTM, etc.) as appropriate. Support process engineering efforts during process scale-up and manufacturing improvement initiatives. Maintain a safe work environment and laboratory notebooks. May mentor or supervise less experienced engineers, interns, and co‑ops. Other duties as reasonably assigned by the management team. Requirements Education Minimum bachelor’s degree in Material Science, Bioengineering, Chemistry, or a related technical discipline. Advanced degree preferred. 4+ years of medical device industry experience. Experience At least 6 years’ engineering experience designing or modifying medical devices or implants. Skills Demonstrated mastery-level knowledge with tissue engineering, biomaterials, and polymers. Design controls. Risk management and creation of risk analyses. Laboratory prototyping. Safety precautions and protocols for safe handling and disposal of hazardous agents, reagents, chemicals, and materials. Effective engineering problem-solving tools. QMS change control. Thorough understanding of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments. Able to apply techniques and independently interpret results. Experience in tissue engineering and biomaterials is a plus. Ability to travel as needed ( Exceptional organizational, communication (verbal and written), and interpersonal skills. Works independently with general direction and minimal supervision. Attention to detail, effective problem solving, and decision-making skills. Knowledge of MS Project software, Outlook, Excel, Word, and PowerPoint. Travel 10% Safety Move or lift objects up to 25 pounds. Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays. Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.). Onsite: Office environment with assigned workstation. Ability to lift and/or carry 50 lbs. #J-18808-Ljbffr