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 LifeAs Quality Engineer you will prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements. You will be serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices.Responsibilities may include the following and other duties may be assigned:
- Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices.
- Drafting and authoring PSUR or CER documents.
- Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities.
- Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance.
- Develop templates and trainings based on the quality system regulations, applicable standards and guidance.
- Independently review all deliverables to ensure compliance with development process and the standard.
- Collaborates with engineering, regulatory affairs and manufacturing functions to ensure submission of safety reports.
- Participate when appropriate in audits.
Required Knowledge and Experience:
- B E or B. Tech in Mechanical/Biomedical Engineering
- Minimum 4 to 8 years of quality engineering experience.
- Familiar with Literature review, PMCF,IMDRF coding, CAPA and NCMR.
- Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
- Hands-on experience on EU MDR, Risk Management, Design Controls for Medical Devices.
- Familiar with ISO 13485, ISO 14971,21 CFR part 820, 21 CFR part 11 and EU MDR and product specific industry standards.
- Understanding of post-market surveillance processes and adverse event reporting.
- Knowledge of risk management principles and hazard analysis in the context of medical devices.
- Good verbal and written communication skills including plan / report development.
- ASQ CQE, CQA, CSQE and/or CRE certification.
- ISO 9001 Internal Auditor / Lead Auditor Certification.
- ISO 13485 Internal Auditor / Lead Auditor Certification.
- Lean Six Sigma Green Belt or Black Belt.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
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If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected].
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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
Skills Required
- Bachelor of Engineering or Bachelor of Technology in Mechanical or Biomedical Engineering
- 4 to 8 years of quality engineering experience
- Experience with literature review, PMCF, IMDRF coding, CAPA, and NCMR
- Hands-on experience with EU MDR, medical device risk management, and design controls
- Familiarity with ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 11, EU MDR, and product-specific industry standards
- Understanding of post-market surveillance processes and adverse event reporting
- Knowledge of risk management principles and hazard analysis for medical devices
- Strong verbal and written communication skills, including plan and report development
- ASQ CQE, CQA, CSQE, and/or CRE certification
- ISO 9001 Internal Auditor or Lead Auditor certification
- ISO 13485 Internal Auditor or Lead Auditor certification
- Lean Six Sigma Green Belt or Black Belt
- Ability to work as a contributor, subject matter expert, leader, and facilitator on cross-functional teams
Medtronic Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Medtronic and has not been reviewed or approved by Medtronic.
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Healthcare Strength — Health coverage is considered comprehensive, with high-quality medical, dental, and vision options through major providers and added mental-health resources. These programs are frequently highlighted as a core strength of the package.
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Parental & Family Support — Parental and family benefits stand out, including up to 24 weeks paid leave for U.S. birthing parents, 12 weeks for other parents, and a global Family Care Leave at 100% pay. Family-building support (fertility, adoption/surrogacy reimbursements) and backup care further reinforce this strength.
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Retirement Support — A 401(k) with company match is described as competitive and reliable for long-term savings. Additional financial programs, such as tuition assistance and charitable-gift matching, complement retirement planning.
Medtronic Insights
What We Do
Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions. Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year. To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.
