Sr Reliability Engineer - Exempt

Join our team in Mounds View, MN, where you will play a pivotal role in enhancing product quality and process capability across our manufacturing sites. As a Senior Reliability Engineer Contractor, you will provide technical leadership and reliability engineering support to ensure supply continuity and reduce risk.

Position Summary

This role partners closely with Manufacturing, Quality, Operations, Supplier Quality, Design Engineering, and Regulatory Affairs to investigate complex issues, implement corrective actions, and drive continuous improvement initiatives. The ideal candidate is a hands-on reliability engineering professional with experience in manufacturing environments, root cause investigation, risk management, and statistical analysis.

Key Responsibilities

• Manufacturing Reliability Support
  • Serve as the primary reliability engineering resource for manufacturing sites and operations teams.
  • Support production, sustaining engineering, and product transfer activities by assessing reliability risks and implementing mitigation strategies.
  • Collaborate with site leadership to identify and prioritize reliability improvement opportunities.
  • Evaluate process changes for potential impact to product reliability and long-term performance.
  • Support manufacturing readiness activities for product launches, transfers, and capacity expansion initiatives.
• Failure Analysis & Investigation
  • Lead investigations of manufacturing nonconformances, quality issues, field concerns, and reliability events.
  • Utilize structured problem-solving methodologies to identify root causes and implement effective corrective and preventive actions.
  • Conduct data-driven analyses to determine failure trends, performance degradation mechanisms, and process variation impacts.
  • Facilitate cross-functional problem-solving sessions and technical reviews.
• Reliability & Risk Management
  • Conduct and support reliability assessments including Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), reliability predictions and modeling, statistical analysis, Design of Experiments (DOE), and process capability analysis.
  • Support risk management activities in accordance with applicable quality system requirements.
  • Identify reliability risks associated with manufacturing processes, suppliers, equipment, and materials.
• Continuous Improvement
  • Drive reliability-focused continuous improvement initiatives that improve product performance and manufacturing efficiency.
  • Analyze manufacturing and field performance metrics to identify opportunities for risk reduction.
  • Recommend and implement process controls that improve consistency and reduce quality escapes.
  • Develop reliability dashboards and performance metrics to monitor effectiveness of improvement activities.
• Cross-Functional Collaboration
  • Partner with Manufacturing Engineering, Quality Engineering, Supplier Quality, Operations, Design Engineering, and Program Management teams.
  • Provide technical guidance on reliability best practices and statistical methodologies.
  • Support audits, inspections, and regulatory inquiries as needed.
  • Present technical findings and recommendations to site leadership and program teams.

Required Qualifications

• Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Industrial Engineering, Quality Engineering, or related technical discipline.
• 7 years of engineering experience in reliability, quality, manufacturing, product development, or related engineering function.
• Demonstrated experience supporting manufacturing operations in a regulated environment.
• Experience leading root cause investigations and corrective action implementation.
• Strong analytical and statistical problem-solving skills.
• Knowledge of reliability engineering principles, methodologies, and tools.
• Ability to influence stakeholders across multiple functions and sites.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience supporting medical device, pharmaceutical, biotechnology, aerospace, automotive, or other highly regulated industries.
• Familiarity with FDA, ISO 13485, ISO 14971, and GMP requirements.
• Experience with Minitab, JMP, ReliaSoft, Statistical process control (SPC), and Design for Reliability (DfR).
• ASQ Certified Reliability Engineer (CRE) or equivalent certification.
• Experience supporting multiple manufacturing facilities or global operations.
• Knowledge of supplier quality and manufacturing validation activities.

Key Competencies

• Manufacturing Reliability
• Root Cause Analysis
• Risk Management
• Statistical Analysis
• Process Improvement
• Failure Analysis
• Quality Systems
• Cross-Functional Leadership
• Technical Problem Solving
• Continuous Improvement