At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

Careers That Change Lives

In this exciting role as a QualityEngineering 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.

Responsibilities may include the following and other duties may be assigned.

• 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.

Qualifications

Must Have: Minimum Requirements

To be considered for this role please ensure the minimum requirements are evident on your resume.

Bachelors 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 Have

• 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)
  

About Medtronic

Together we can change healthcare worldwide. At Medtronic we push the limits of what technology therapies and services can do to help alleviate pain restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Travel up to 25% domestic and international.

Primary Location:North America-United States-Minnesota

Other Locations:North America-United States-Massachusetts

For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Join us in our mission to alleviate pain restore health and extend lifewhere your unique background and perspective are valued.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.