We are looking for Reliability Engineer for our client in ??Mounds View, MN
Job Title: Reliability Engineer
Job Location: ??Mounds View, MN
Job Type: Contract – 12 Months / Contract to Hire / Direct Hire
- Experience Level (Years) 5+
- The Reliability Engineer provides reliabilityengineeringsupport of new product development programs for Mechanical Circulatory Support (MCS) products, specifically in risk management. The purpose of this role is to apply knowledge to complete risk management files (design FMEAs) while ensuring timely, accurate and independent evaluation of product performance and safety prior to clinical studies or market release.
- 3+ years in Quality Engineering, Quality Assurance, Product Development, or manufacturing with a B.S. degree OR 2+ years with a master’s degree in engineering
- Excellent understanding of typical customer use of medical products.
- Previous experience in the medical device industry in a quality, reliability, development, research or safety role.
- Ability to independently lead development of risk management files (Risk management plan, design FMEAs, etc) and to help identify system/product failures, hazards, hazardous situations, and harm.
- Working knowledge of ISO 14971 (Application of risk management to medical devices) and 21 CFR part 820 (FDA Quality System Regulation).
- Represents the quality function in product development teams/projects for reviewing plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory).
- Maintains expertise in international safety standards and serves as a resource to assist in the development of products that meet all international requirements.
- Ensures team compliance of relevant safety regulations, QSRs, ISO Standards, CMDR, MDD
- Understanding of medical device (21CFR 820 & ISO13485) regulatory standards and engineering applications
- Green Belt/Black Belt certification preferred
- Ability to communicate effectively in multi-discipline environment, and cross cultures and level of organization
- Proficient verbal and written communication skills; including experience in writing and presentation skills
- Bachelor of Science in Engineering