Reliability Engineer II

Job Title Reliability Engineer II Position Details Location: Mounds View, Minnesota 55112 Duration: 12 months Pay rate: $45–$50/HR (W2) Responsibilities Setup and execution of test methods for test method validation or design verification. Report writing and approval. Review of design, manufacturing, and supplier change orders. Perform reliability activities such as design verification, reliability testing, test method validation. Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability. Complete risk analysis studies of new or existing design and processes. Compile and analyze performance reports and process control statistics; investigate and analyze variables that may affect product and process reliability. Ensure corrective measures meet acceptable reliability standards. Analyze preliminary plans and develop reliability engineering programs to achieve company, customer, and governmental agency reliability objectives. Develop mathematical models to identify units, batches, or processes posing excessive failure risks. Propose changes in design or formulation to improve system and/or process reliability. Determine units and/or batches requiring environmental testing and specify minimum number of samples for statistically valid data. Deliver and oversee projects from design to implementation, ensuring adherence to policies and using specialized knowledge. Requirements Bachelor’s degree in Engineering, Science or a technical field with at least 1 year of work experience in Engineering and/or Quality. Experience in reliability testing, design verification, test method validation. Strong written and verbal communication skills. Ability to work cooperatively as part of a cross‑functional team. Nice to Have 1+ years of medical device industry experience. Familiar with FDA 21 CFR Part 820 and EU MDR (EU 217/745). Familiarity with ISO 13485, ISO 14971, and IEC 60601 standards. Knowledge of client office applications (Word, Excel, Access, PowerPoint) and Windows OS. Products Supported Affera disposable products: Sphere‑9, Tubing Set, and Extension Cable. Experience Target years of experience: 2–4 years. Start Date As soon as possible. Interviewing to begin in March. #J-18808-Ljbffr