We anticipate the application window for this opening will close on - 9 Oct 2026
A Day in the LifeMedtronic'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 escalate 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 0 years of work experience
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. a7 214.2(h)(4)(iii)(A) is required.
Physical Job RequirementsThe 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.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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, 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