Principal Quality Engineer
About the role
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 At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. The Cardiac Surgery Operating Unit develops and delivers innovative surgical solutions that enable surgeons to treat complex heart conditions, including coronary artery disease, structural heart disease, and cardiopulmonary support needs. In this exciting role as a Principal Quality Engineer supporting the Post Market Quality organization, you will provide technical leadership across all quality aspects of the commercial portfolio, including Health Risk Assessments, Post Market Surveillance, and Risk Management. You will serve as a key partner to cross functional teams, guiding critical quality decisions that protect patients and ensure sustained product performance. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.
But note schedule info is also in About the role; we might move schedule to its own section. However we can keep schedule info in About the role and also have Schedule section referencing. To avoid duplication, maybe we keep schedule info only in Schedule section and remove from About the role. But About the role currently includes that sentence; we could keep it but then Schedule section would duplicate. Better to keep About the role without schedule details, and put schedule details in Schedule section. Let's edit About the role to exclude schedule and travel sentences. Thus About the role paragraph ends before "In-person exchanges are invaluable..." We'll cut there. Now Responsibilities: list from "Responsibilities may include the following and other duties may be assigned:" then bullet list. We'll create- items.
We need to capture each bullet:
- Risk Management: Support risk assessments and hazard analyses based on post-market data. Lead Health Risk Assessments to determine potential risk and recommend need for Field Corrective Action (FCA).
- Post-Market Surveillance: Monitor product performance in the field, collect and analyze reliability data, and identify trends and potential issues.
- Root Cause Investigation and Failure Analysis: Lead investigations into product failures and complaints, utilizing root cause analysis techniques to determine underlying causes. Support complaint trending and investigations of complaint trend excursions or quality signals from the field.
- Design Control: Assess design and risk impacts of changes; generate, review, and approve FMEAs, test method validations, and verification and validation test reports in compliance with medical device design control requirements.
- Continuous Improvement: Collaborate with design, manufacturing, and quality teams to implement design, process or supplier changes, corrective and preventive actions that enhance product reliability.
- Customer Interaction: Provide technical support to customers and field personnel regarding reliability issues and product performance.
- Coaching: Provide technical mentorship and coaching to junior engineers.
We'll output as list.
Next Requirements (Must Haves): The "Must Haves: Required Qualifications" block. We'll put as
- items.
Content:
- Requires a Baccalaureate degree in Science, Technology, Engineering, Math or a related technical discipline with a minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant 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.
We could also include Physical Job Requirements? Might be separate but we can incorporate under Requirements as a note: "Physical Job Requirements: 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions." We'll add as a list item.
Next Qualifications (Nice To Haves - Preferred Qualifications): list:
- Prior experience in the medical device industry across product development, operations, or quality functions.
- Demonstrated expertise in risk management in accordance with ISO 14971.
- Strong technical writing and communication skills, with the ability to clearly explain complex technical topics to non-technical audiences.
- Proven ability to lead root cause investigations, solve complex technical problems, and perform statistical data analysis.
We'll put as list.
Next Benefits: list of benefits.
From Benefits & Compensation: "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."
We'll create a list.
Next Pay: Salary range: "$132,000.00 - $198,000.00". Also mention short-term incentive Medtronic Incentive Plan (MIP). Also note base salary range applicable across US excluding PR and specific locations in California. Also note compensation may vary based on factors. We'll include as
maybe. Next Schedule: "We are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects." We'll put as
. We must not include boilerplate like EEO, Fraud Alert, etc. Also remove "U.S. Work Authorization & Sponsorship" maybe? It's substantive but not in allowed headings; we could fold into Requirements as a note about sponsorship. But the instruction says use headings from list; we can add a paragraph under Requirements about sponsorship. Let's include a sentence: "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." This is relevant. We'll add that as a list item under Requirements. Now ensure we don't repeat job title. No headings for Job ID. Now produce HTML fragment. Let's craft:
About the role
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 At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. The Cardiac Surgery Operating Unit develops and delivers innovative surgical solutions that enable surgeons to treat complex heart conditions, including coronary artery disease, structural heart disease, and cardiopulmonary support needs. In this exciting role as a Principal Quality Engineer supporting the Post Market Quality organization, you will provide technical leadership across all quality aspects of the commercial portfolio, including Health Risk Assessments, Post Market Surveillance, and Risk Management. You will serve as a key partner to cross functional teams, guiding critical quality decisions that protect
- items.
Content:
- Requires a Baccalaureate degree in Science, Technology, Engineering, Math or a related technical discipline with a minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant 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.
We could also include Physical Job Requirements? Might be separate but we can incorporate under Requirements as a note: "Physical Job Requirements: 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions." We'll add as a list item.
Next Qualifications (Nice To Haves - Preferred Qualifications): list:
- Prior experience in the medical device industry across product development, operations, or quality functions.
- Demonstrated expertise in risk management in accordance with ISO 14971.
- Strong technical writing and communication skills, with the ability to clearly explain complex technical topics to non-technical audiences.
- Proven ability to lead root cause investigations, solve complex technical problems, and perform statistical data analysis.
We'll put as list.
Next Benefits: list of benefits.
From Benefits & Compensation: "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."
We'll create a list.
Next Pay: Salary range: "$132,000.00 - $198,000.00". Also mention short-term incentive Medtronic Incentive Plan (MIP). Also note base salary range applicable across US excluding PR and specific locations in California. Also note compensation may vary based on factors. We'll include as