Reliability Engineer II - Exempt

Join our dynamic team in Mounds View, MN, and contribute to the development of cutting‑edge technologies in a collaborative and innovative environment. We are seeking a dedicated professional to enhance our product reliability and ensure our engineering processes meet the highest standards.

• 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.

• 1 year of Medical Device industry experience.
• Familiarity with FDA 21 CFR Part 820, EU 217/745 (EU MDR).
• Knowledge of standards: ISO 13485, ISO 14971, IEC 60601.
• Proficiency in Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.

• Perform reliability activities such as design verification, reliability testing, and test method validation.
• Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts and 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 relevant variables potentially affecting product and processes.
• Ensure that corrective measures meet acceptable reliability standards.
• Analyze preliminary plans and develop 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.
• Propose changes in design or formulation to improve system and/or process reliability as necessary.
• Determine units and/or batches requiring environmental testing, and specify minimum number of samples to obtain statistically valid data.

• Target years of experience: 2-4 years.
• Start date:
  
  ASAP.
• Work location:
  
  Onsite in Mounds View, MN.

If you are ready to take on a challenging role and make a significant impact, we encourage you to apply and become a part of our team in Mounds View, MN.