Details: Stefanini Group is hiring! Stefanini is looking for Engineer - Disposables R&D, Sustaining in Plymouth, MN (Hybrid) Work Hours:  M-F (40 hours) Work Location:  Plymouth, MN (Hybrid) Shift:  1st Shift

Create new 3rd party supplier documentation including design specifications, labeling, design drawings, etc. for peritoneal dialysis disposable sets. Create, modify, and maintain design history files. Perform change control assessments. Work closely with project manager and technical lead to achieve project commitments. Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. Job Requirements Details: Qualifications and Expertise: BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred. Pharma industry background is required. 3 - 5 years of related experience in Class II or Class III disposables medical product development. Design for Six Sigma (DFSS) training or certification preferred. Experience working with external manufacturing partners and supplier relations. Experience creating and modifying medical device design outputs including receiving and inspection criteria. Experience in medical device product support and change control management. Experience in design transfer from R&D to manufacturing. Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems. Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices. Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements. Strong collaboration, verbal and written communication skills. Strong attention to detail, organized, and able to independently manage multiple priorities. Ability to read, write and comprehend English.

Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives. About Stefanini Group The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company. #LI-VB1 #LI-HYBRID