Quality Engineer II
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
Team is working hybrid and position will be onsite 2 days/week in Carlsbad, CA.
At our Quality Engineering department in Medtronic, plc, we focus on providing Engineering support for Design and Development, Quality Compliance, and Risk Management activities across the Ventilation Service Solutions portfolio. As a Quality Engineer II, you will work within a team of four engineers to apply Design Controls and Risk Management principles to ensure that any changes to our sustaining ventilation products are safe, effective, and compliant to associated Regulations and Methods.
Responsibilities may include the following and other duties may be assigned:
• Responsible for ensuring that mechanical, electrical, software, and labeling changes to existing products (ventilators and accessories) are conducted in compliance with the FDA Quality System Regulations and EU MDR requirements. This position will focus on software design changes.
• Responsible for approving product requirements and modified product designs for quality characteristics, including reliability, maintainability, serviceability, and testability.
• Participate on cross-functional teams to maintain Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA and Risk Management Report) and facilitate Post Launch Risk Management Reviews.
• Participate in Post-Market Surveillance and signal detection activities. Provide Quality support to facilitate the rapid resolution of Product Complaints and/or Patient Safety issues. Author Issue Impact Assessments (IIA/HHE).
• Participate in the development of Design Verification and Validation Test Plans / Protocols and provide guidance on Standards compliance.
• Challenge proposals during Formal Technical Design Reviews.
• Provide guidance and direction for sample size and test method validation.
• Provide guidance to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods, risk management, and design controls).
• Review Design History Files and EU MRD files for conformance to applicable requirements and support occasional Regulatory Affairs activities.
• Participate in the CAPA process.
• Provide assistance during Compliance audits.
Minimum Requirements
• Bachelor's degree plus 2+ years of quality or engineering experience (Or 0+ years with an advanced degree)
Nice to Have
• Bachelor’s or Master’s Degree in Engineering, Physics, Science fields, or Math
• 3+ years industry experience Quality Assurance, R&D, or Regulatory Affairs in Medical Device or Pharmaceutical Industries.
• Familiarity with Medical Device Quality Systems (21 CFR 820, ISO-13485, and EU MDR)
• Familiarity with ISO-14971 and IEC-62304
• Excellent written and verbal communication skills
• Proficiency with MS Office, Outlook, PowerPoint, and Teams
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.
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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At Medtronic, we are all about innovation and healthcare equity, and we're on the lookout for a Quality Engineer II to join our Quality Engineering team in Carlsbad, California! Picture yourself immersed in the exciting world of medical devices, where you'll help ensure that ventilators and their accessories are safe, effective, and compliant with regulations. As part of a dynamic team, you'll dive into the nitty-gritty of Design Controls and Risk Management for our sustaining ventilation products. Your day-to-day might involve approving modifications to product designs, working collaboratively on Risk Management Files, or participating in Post Market Surveillance to track product performance and resolve patient safety issues. If you enjoy probing into software design changes while ensuring adherence to FDA and EU standards, this role is perfect for you. With a minimum requirement of a bachelor's degree and two years of engineering experience, you'll be equipped to tackle industry challenges. We value clear communication, and your ability to interact with technical teams will be crucial. Join us in Carlsbad, where working hybrid allows for the best of both worlds - collaborating on-site and enjoying flexibility. Medtronic is more than just a job; it's a chance to contribute meaningfully to healthcare innovations that can change lives. Ready to take on the challenge and make your mark with us?
Mission Written in 1960, our Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees aroun...
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