Senior Quality Engineer

Senior Quality Engineer

Medtronic's Interventional Cardiology Therapies (ICT) operating unit is seeking a Senior Quality Engineer to lead and execute post market surveillance activities while serving as a key technical leader within Post Market Quality. This role provides strategic oversight of complaint investigations, complaint trending, risk assessments, regulatory support activities, and quality system improvements across the ICT operating unit. The Senior Quality Engineer will serve as a subject matter expert for post-market quality processes and partner closely with Regulatory Affairs, Clinical Affairs, Medical Safety, R&D, Manufacturing, and Global Quality to evaluate product performance, identify emerging risks, and drive continuous improvement initiatives. The role will also provide mentorship to junior engineers and influence quality strategy for new and released products. This position is in Santa Ana, CA and requires on-site presence for 4 days a week. This position is not open to remote candidates or sponsorship.

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

• Lead complex complaint investigations, product performance assessments, and root cause analyses for commercially released products
• Drive periodic complaint trending activities, identify and evaluate emerging quality signals, assess patient and business risk, and recommend appropriate actions
• Provide technical leadership in evaluating complaint data, post-market surveillance information, and field performance trends to support risk management activities
• Collaborate with cross-functional teams including Customer Quality Experience Management, Clinical Affairs, Medical Safety, Regulatory Affairs, R&D, Manufacturing, and Reliability Engineering to resolve complex quality issues
• Lead quality assessments supporting regulatory submissions, product registrations, regulatory inquiries, and responses to health authority requests
• Serve as a subject matter expert for post-market surveillance and complaint handling processes during internal and external audits
• Partner with Design Assurance and Risk Management teams to review and evaluate risk files, hazard analyses, FMEAs, benefit-risk assessments, and post-market surveillance strategies
• Lead development, maintenance, and continuous improvement of Periodic Safety Update Reports (PSURs), Post-Market Clinical Follow-up activities, and other post-market regulatory deliverables
• Identify opportunities for process improvement and lead initiatives that enhance quality system effectiveness, operational efficiency, and product quality
• Provide technical guidance and mentoring to engineers and investigators while promoting best practices in problem solving and risk-based decision making
• Influence quality decisions through sound engineering judgment, data analysis, and effective communication with leadership and cross-functional stakeholders
• Prioritize and communicate significant quality concerns, emerging risks, and compliance issues to management and executive leadership as appropriate
• Participate in CAPA, nonconformance, and risk evaluation activities, ensuring robust investigation, containment, and corrective actions

Preferred Qualifications

• Advanced degree in engineering, science, or equivalent technical discipline
• Knowledge of cardiovascular/implant procedures
• Experience with post-market surveillance requirements, complaint handling, risk management, and product performance monitoring
• Experience with statistical analysis, data trending, and signal detection methodologies
• Experience in a highly regulated industry, preferably implantable medical devices
• Knowledge of product development cycles including clinical and regulatory requirements
• Demonstrated leadership of cross-functional projects and process improvement initiatives

Required Qualifications

• Bachelor's degree in engineering, health science, or a technical discipline
• 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

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.

Recruitment Fraud Alert

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.

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If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io.

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.

Salary ranges for U.S (excl. PR) locations (USD):$98,400.00 - $147,600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple 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 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), and Capital 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

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.

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic