Reliability Engineer II (12-month contract // Mounds View, MN // W2 ONLY):

Top Skills:

1. Experience supporting, coordinating and / or leading projects.
2. Remediation experience (DHF, Regulatory compliance, e.g., EU MDR, UKCA).
3. Experience in development of new or existing medical devices.
4. Knowledge of industry standards (ISO 13485) and regulations, specifically EU MDR and UKCA.

Duties:

• 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 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.

Required Knowledge and Experience:

• Requires a University Degree and 1-3 years of relevant experience, or advanced degree with 0 years of experience.

Preferred Skills:

• Solid understanding of engineering fundamentals and proven hands-on electronic/mechanical skills.
• Demonstrated ability to perform as a contributing member of cross functional teams, including quality, electronic, and mechanical engineers.
• Analytical with strong problem-solving abilities and creative resolution skills.
• Proficient in Microsoft office programs including Excel and Word.
• Organize and be able to prioritize workload, meet multiple deadlines simultaneously in a fast-paced environment.
• Strong communication skills [oral and written] including listening; and ability to maintain clear project status and interlocks with internal project teams and external test agencies.
• Strong interpersonal skills: function as a “team player” and work constructively and cooperatively with all team members in the best interests of the program.