Senior Quality Engineer - Post Market Surveillance - Irvine, CA (Onsite)

We anticipate the application window for this opening will close on - 28 Feb 2025

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 LifeIn this exciting role as the Senior Quality Engineer, you will be responsible for optimizing patient care by timely resolutions of post-market quality and product safety issues. The position ensures adequate engineering evaluation of field reported complaints including trends in patient impact, device failures, root cause investigation, and on-going risk assessment driven by data analytics and signal detection for neurovascular product sustenance and improvements. This individual will support all Neurovascular products and expected to apply his/her knowledge of Design Control, Risk Management principles and quality engineering techniques, statistics, and data analytics to monitor post market product safety and ensure conformance to all applicable regulatory requirements. Collaborate with Neurovascular cross-functional teams to drive appropriate product control based on risk evaluation.
Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Neurovascular Operating Unit

The Neurovascular Operating Unit provides a comprehensive portfolio of proven, powerful neurovascular technologies, setting the highest standards of integrity and reliability in Acute Ischemic and Hemorrhagic Stroke Care. 

A Day in the Life

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

• Issue Escalation and Evaluation:

  • Ensuring product safety and optimizing patient care with timely resolutions of post-market quality and safety issues through issue evaluation and risk assessments. 

  • Lead/facilitate the investigation of complex technical issues and collaborate with the cross-functional partners (Manufacturing Operations, Regulatory, R&D, Supplier Quality, etc.) on appropriate actions.

  • Evaluate the impact of issues on product including advanced complaint root cause investigation, health hazard analysis, product hold orders, and field corrective action.

  • Support product evaluation board processes for complaint trending and signal analysis.

• Risk Management:

  • Identifies and manages risk throughout the product lifecycle with the application of risk management tools. 

  • Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.

  • Maintains knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.

  • Comply with applicable FDA and international regulatory laws/standards and Medtronic Neurovascular QA procedures.

  • Adept at using large data sets using a variety of data mining/data analysis methods and understanding of fundamental Risk Management application.

  • Comprehensive understanding of all Neurovascular products and clinical uses.

Must Have (Minimum Requirements)

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

• Bachelor’s degree in engineering, Science, or Technical Discipline required with minimum of 4 years of experience,

• or advanced degree in engineering, Science, or Technical Discipline with a minimum of 2 years’ experience

Nice to Have (Preferred Qualifications)

• Demonstrated proficiency in decision making – preferably across a broad spectrum of Quality Engineering responsibilities

• Project management methods and tools

• Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)

• ASQ Certification is highly desirable

• In depth knowledge of Risk Management and Analysis as well as Statistics background is desired.

• Process Improvement Methodologies, such as Six sigma, DOE, LEAN

• ISO standards including ISO13485 Medical Device Directives (MDD)/Vigilance Reporting, EU

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.

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):$94,400 - $141,600

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

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 90,000+ 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.