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

The Complaint Investigation Engineer role is critical to ensuring product quality, patient safety, and regulatory compliance. This position is responsible for leading and managing complaint investigations, performing thorough root cause analysis, and driving effective Corrective and Preventive Actions (CAPAs). The role also oversees risk management activities through the Internal Investigation Assessment (IIA) process to ensure that potential risks are properly evaluated and mitigated.

Additionally, this position is responsible for analyzing and trending complaint data to identify systemic issues and opportunities for continuous improvement. Effective management of complaint investigations and CAPA activities is essential to maintain compliance with quality system regulations and internal procedures.

Given the direct impact that complaint investigations have on product performance, regulatory reporting, and overall quality system effectiveness, this role plays a vital part in protecting patients, supporting business continuity, and ensuring that issues are promptly identified, investigated, and resolved.

         

         

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

• Lead and manage complaint investigations to ensure timely and thorough resolution.
• Conduct risk management activities through the Internal Investigation Assessment (IIA) process.
• Perform detailed root cause analysis to identify underlying issues.
• Develop, implement, and monitor Corrective and Preventive Actions (CAPAs).
• Analyze and trend complaint data to identify systemic issues and opportunities for improvement.
• Ensure investigations, risk assessments, and CAPA activities are completed in compliance with applicable quality and regulatory requirements.
• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Must Have: Minimum Requirements-

• Engineering bachelor’s degree required
• minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
• Root Cause Analysis
• Investigation knowledge (CAPA, complaint, nonconformance etc.)

Nice to Have

• ·       Validation IQ/MSA/OQ/PQ knowledge
• ·       Risk Management knowledge
• ·       Project Management knowledge
• ·       Microsoft Project, Minitab
• ·       Problem Solving
• ·       Pressure management
• ·       Teamwork
• ·       Time management
• ·       Attention to detail

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 impact. In 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 life—where 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.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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 95,000+ 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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.