Reliability Engineer

Reliability Engineer II (Through April 2027 // Mounds View, MN) Required Skills

• Design Assurance / Reliability Engineering
• Test Method Development
• Test Method Validation

• 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

2-4 years

• Perform reliability activities (design verification, reliability testing, test method validation, etc.).
• Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
• Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new or existing design and processes.
• Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
• Ensures that corrective measures meet acceptable reliability standards.
• Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer, and governmental agency reliability objectives.
• May develop mathematical models to identify units, batches or processes posing excessive failure risks.
• As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

• Bachelor's Degree in Engineering, Science or technical field with 1+ years of work experience in Engineering and/or Quality
• Experience in Design Assurance/Reliability Testing, Design Verification, Test Method Validation
• Strong written and verbal communication skills
• Ability to work cooperatively as part of a cross-functional team

• 1+ years of Medical Device industry experience, ideally for catheter manufacturing
• Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR)
• Familiar with these standards: ISO 13485, ISO 14971, IEC 60601
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.