Find & Apply For Validation Engineer Jobs in Mounds View, Minnesota

Can you please confirm your top 3 skills sets required? Manufacturing support, Project and program support, cross functional collaboration Can you please confirm the 3 main responsibilities/day to day activities required for this role? Supporting multiple sites, being a site representative, understanding quality/post market quality deliverables What products (if any) will this role support? (Pacemakers and leads) What is your target years of experience? 5-15 years Position Summary The Senior Reliability Engineer Contractor will provide technical leadership and reliability engineering support across manufacturing sites to improve product quality, reduce risk, enhance process capability, and ensure supply continuity. 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. This individual will be expected to quickly assess reliability concerns, provide technical recommendations, and lead cross-functional teams to resolve manufacturing and field performance challenges. 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)
• 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)
• 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