Documentation Specialist Engineer
Job Type: W2, Contract
Job Location: Minneapolis, Minnesota 55441
- Hybrid, 3 days on-site per week
Pay Rate: $35 – $37 an hour
Join our team as a Documentation Specialist Engineer – Disposables R&D and play a crucial role in shaping the future of peritoneal dialysis disposable sets. Offers a unique opportunity to work with external manufacturing partners, create innovative designs, and ensure compliance with FDA and international regulations.
Essential Skills & Qualifications:
- Experience working with external manufacturing partners and supplier relations.
- Updating and Managing Documentation.
- Expertise in creating and modifying medical device design outputs, including receiving and inspection criteria
- Proven track record in medical device product support and change control management
- Experience in design transfer from R&D to manufacturing
- Strong knowledge of FDA Design Controls and ISO 13485 Quality Management Systems
- Familiarity with ANSI/AAMI/ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
- Strong collaboration, verbal, and written communication skills
- Attention to detail, organized, and ability to independently manage multiple priorities
- Ability to read, write, and comprehend English
Nice to Have Skills:
- Design for Six Sigma (DFSS) training or certification
- Experience with peritoneal dialysis disposable sets or related medical devices
Preferred Education and Experience:
- BS in Mechanical, Plastics, Biomedical Engineering, or a related field; MS preferred
- 3-5 years of related experience in Class II or Class III disposables medical product development
Other Requirements:
- Ability to work in a fast-paced environment and meet project commitments
- Willingness to travel to company offices (at least 3 days a week) and collaborate with team members
- Strong initiative and aptitude for learning, innovation, and implementing best practices and continuous improvements