Quality Engineer II

Regulatory Jobs; Santa Ana (CA); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) plan with employer contribution

Job summary

Medtronic in Santa Ana, CA seeks a Quality Engineer II to own post‑market surveillance, including complaint investigations, data trending, and regulatory submissions. The role requires on-site presence four days a week and involves cross‑functional collaboration with R&D, regulatory affairs and manufacturing.

A bachelor’s in engineering/health science is required; advanced degrees are a plus. Responsibilities include leading investigations, preparing regulatory responses, maintaining PSURs, and

Qualifications

• Bachelor's degree in engineering, health science or technical discipline is required.
• 2+ years of work in engineering or science, or an advanced degree with 0 years experience.
• Experience with post-market quality, complaint investigations and regulatory interactions is desirable.

Responsibilities

• Lead complaint investigations and periodic data trending to assess risks.
• Collaborate with cross-functional teams for thorough investigations.
• Prepare responses to regulatory queries for registrations/submissions.
• Partner with design assurance on risk analysis and PM surveillance plans.
• Own PSURs and drive improvements to processes and systems.

Skills

Analytical thinking

Quality mindset

Cross-functional collaboration

Regulatory awareness

Education

Bachelor's degree in engineering/health science/technical discipline

Advanced degree preferred

Tools

DFMEA

PSURs

Job description

We anticipate the application window for this opening will close on - 9 Oct 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

Medtronic's Interventional Cardiology Therapies (ICT) operating unit is seeking a Quality Engineer II to own and execute post market surveillance activities. Furthermore, this role is responsible for overall operation of Post Market Quality specifically overseeing the execution of complaint investigations, complaint trending, providing complaint data for regulatory inquiries and submissions, PSURs, etc. within the ICT operating unit.

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 complaint investigations, conduct periodic trending of complaint data, evaluate negative trends, assess risk to released products which aids in determining appropriate field actions and analyze explants and returned products, as required
• Collaborate with cross functional teams like customer quality experience management, clinical affairs, medical safety, R&D engineering and manufacturing to perform thorough complaint investigation
• Prepare appropriate responses to regulatory queries for product registrations and other regulatory submissions by working with the regulatory affairs team
• Partner with design assurance team on risk analysis of new products by reviewing files such as product hazard analysis, DFMECA, post market surveillance plan, risk management report, etc.
• Own and maintain periodic safety update report (PSUR) by collaborating with several cross-functional teams for applicable devices
• Develop solutions to unique issues with wide range of difficulty; Improve upon existing processes and systems using significant conceptualizing, reasoning and interpretation across functions and/or businesses which may cause redirection
• Prioritize timely presentation of quality issues and elevate to leadership based on sound engineering, analysis & review for the success of the business

Preferred Qualifications:

• Advanced degree in engineering, science, or equivalent technical discipline
• Knowledge of cardiovascular/implant procedures
• Experience in a highly regulated industry, preferably implantable medical devices
• Knowledge of product development cycles including clinical and regulatory requirements

Required Qualifications:

• Bachelor’s degree in engineering, health science, or a technical discipline
• Minimum of 2 years of work experience in engineering or science, OR advanced degree in engineering, science, or technical discipline with 0years of work 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.

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):$79,200.00 - $118,800.00

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, 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 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), 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

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 reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.