Medtronic

Senior Quality Engineer - Projects (Onsite)

Northridge, CA US
R
Description
We anticipate the application window for this opening will close on - 1 Apr 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 Life

At Medtronic Diabetes, we are looking for a Senior Quality Engineer who will have responsibility for providing technical and quality systems expertise within the Operations Quality organization.  You will serve as a subject matter expert by providing support for Diabetes commercialized products and projects.  Our quality team is looking for talented career engineers to join our organization. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. This role will be part of Electronic Technologies and China Operations Quality team.  Individuals in this role will provide technical support and quality system expertise for commercialized Diabetes products including Continuous Glucose Monitoring Systems (CGMS) and product accessories.  The ideal candidate for this position has a strong technical background and experience in medical device product manufacturing.

Location: Northridge, CA (100% on-site)

Travel: Periodic travel expected, approximately 10%

Our team is unique in that we can adapt to a variety of business, patient and marketplace needs that span the entire spectrum of our product portfolio today and in the future. Our mission drives the need to be a highly skilled, flexible, extremely efficient, versatile and agile in medical device product development for the benefit of our patients with Type 1 and Type 2 diabetes in need of intensive insulin therapy.

Diabetes impacts over 500 million people around the world — that’s roughly one in 10 adults. That means you probably know someone affected by this disease.  At Medtronic, our Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions is designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

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

  • Develop, modify and maintain quality system procedures

  • Support internal or external audit activities where needed. Support nonconformance investigations and dispositions.

  • Collaborate with operations, manufacturing, engineering and regulatory functions to ensure quality standards are in place.

  • Support new product introduction activities with product design transfer efforts, reviewing and approving plans and reports and supporting design qualifications.

  • Support process validations, engineering changes, and risk management activities.

  • Understand complex issues and consult with various functions to conduct meaningful analyses.

  • Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations

  • Leading and/or supporting CAPA projects and assisting post market analysis.

  • Work under consultative direction toward predetermined long-range goals and objectives.

  • Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others.

  • Experience with FDA 21 CFR Part 820 FDA Quality System Regulation, MDSAP, ISO 14971 risk management and/or other relevant international standards.

  • Certified Lean or Six Sigma Black Belt or experience in DMAIC methodology

  • Perform other related duties as assigned

Must Haves: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

  • Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality

Nice to Haves:

  • 5+ years of related quality engineering experience

  • Previous Quality experience working in medical device or related industry

  • Experience with FDA 21 CFR Part 820 FDA Quality System Regulation, MDSAP, ISO 14971 risk management and/or other relevant international standards.

  • Certified Lean or Six Sigma Black Belt or experience in DMAIC methodology

  • Experience with FTQ

  • Working knowledge of hardware development for medical devices.

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):$94,400.00 - $141,600.00

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

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.

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.

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