Engineering Manager

Medtronic

1d • $142,400 - $213,600 • Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life In this exciting role as a Quality Engineering Manager in Post Market Quality, you will provide leadership within the Cardiac Ablations Solutions (CAS) Operating Unit (OU). You will have responsibility for directing and managing a technical team, supporting returned complaint product and data analysis activities for Medtronic Cardiac Ablation Solutions (CAS), supporting all aspects of the quality system. Careers That Change Lives In this exciting role as a Quality Engineering Manager in Post Market Quality, you will provide leadership within the Cardiac Ablations Solutions (CAS) Operating Unit (OU). You will have responsibility for directing and managing a technical team, supporting returned complaint product and data analysis activities for Medtronic Cardiac Ablation Solutions (CAS), supporting all aspects of the quality system. The CAS Returned Product Analysis (RPA) Lab is part of the Post-Market Quality Organization, responsible for ensuring CAS products remain safe and effective through the entire product life cycle. This role will have responsibilities in planning and prioritizing team activities and deliverables related to the function, while ensuring timely, accurate and compliant evaluation of returned product and data analysis required for complaint investigations. This role is responsible for managing laboratory processes and equipment to support quality investigations, root cause analysis, and continuous improvement initiatives. The product analysis lab Manager will partner closely with RPA lab investigation engineers, Reliability, Manufacturing, Design, Regulatory, and Field organizations to ensure investigation outcomes support product quality, patient safety, and regulatory compliance. Cardiac Ablation Solutions Cardiac Ablation Solutions offer cardiac mapping and ablation solutions to treat patients with abnormal heart rhythms. Our vision is to help patients worldwide by advancing innovation for the diagnosis and ablation of cardiac arrhythmias, enabling clinicians to perform procedures with superior outcomes. A Day in the Life The RPA Lab Manager builds a functional team by focusing on developing trust, encouraging productive conflict, gaining commitment of the team members who are accountable to each other and ultimately achieving results. This individual ensures the team possesses the appropriate mix and level of skills required to develop and deliver high quality results in a dynamic growth environment. As part of this, the RPA Lab Manager plans staffing and lab requirements and budgets to support current and future business needs.

Requirements

• Bachelor's degree in Engineering, Science or Technical Field with 5+ years of experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or Technical field with 3+ years of experience in Engineering and/or Quality

Nice To Haves

• Leadership experience, directly or indirectly responsible for managing tasks for other individuals.
• Experience in a highly regulated industry, preferably implantable medical devices
• Experience in quality, engineering, laboratory, or manufacturing environments, Complaint Handling, CAPA and Post-Market surveillance processes.
• Knowledge of Lean, Six Sigma, Design for Reliability and Manufacturability (DRM), and robust design practices.
• Experience working across geographies and cultures.
• Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact.
• Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools.
• Experience in the Class III medical device industry and its regulations (21 CFR 820, European Medical Device Regulation, ISO 13485, ISO 14971, etc.)
• Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others’ needs, negotiate for win-win, own the whole)

Responsibilities

• Manage daily operations of the Returned Product Analysis laboratory, including sample intake, prioritization, disinfection, testing, documentation, retention and reporting.
• Ensure analyses are conducted in accordance with approved procedures, quality system requirements, and regulatory standards.
• Oversee laboratory equipment qualification, calibration, maintenance, and utilization.
• Monitor workload, turnaround times, and performance metrics to meet business and quality objectives.
• Lead, coach, and develop RPA laboratory staff, including hiring, onboarding, training, and performance management.
• Partner with Quality Engineering, Manufacturing, R&D, Supplier Quality, and Regulatory teams to support investigations and corrective actions.
• Ensure compliance with applicable quality system regulations, internal procedures, and safety requirements.
• Support audits and inspections by providing documentation, data, and subject matter expertise.
• Drive consistent and thorough root cause analysis and corrective action recommendations.
• Ensure proper handling, documentation, and disposition of returned products.
• Provide technical input and investigation findings to complaint handling, CAPA, risk management and leadership.
• Identify and implement process improvements to increase efficiency, consistency, and quality of investigations.
• Establish clear expectations, goals, and accountability for team members.
• Foster a culture of quality, safety, collaboration, and continuous improvement.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees