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In Digital Technologies (DT), part of Medtronic’s Medical Surgical Portfolio, we believe patients around the world deserve access to quality care and improved outcomes. We strive to expand global access to care and reduce variability through robotic and laparoscopic and AI/ML analytics-based solutions.

We are seeking a highly skilled and experienced Senior Systems Quality Engineer to join our innovative team. The ideal candidate will have a strong background in New Product Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. This role will be pivotal in ensuring the development and maintenance of high-quality, reliable, and safe medical devices that meet or exceed regulatory standards and customer expectations.

A Day in the Life

• Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards.

• Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle.

• Conduct risk assessments and manage risk mitigation activities in accordance with ISO 14971 and other applicable standards.

• Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections.

• Define and manage systems requirements to ensure clarity, completeness, and testability. Collaborate with the system engineering team to define, refine, and manage system level requirements to ensure alignment with customer needs, clarity, completeness, and testability.

• Develop and manage risk management plans and reports and conduct regular risk reviews.

• Collaborate with the system engineering team to define thorough hazard analysis to identify potential risks and mitigate them effectively.

Must Haves

• Bachelor’s degree in engineering with 8 years of related experience or an advanced degree with 6 years of medical device regulatory affairs or related experience.

• In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.

• Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.

• Good communication skills and the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.

Nice to Haves

• Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification is preferred.

• Experience in Quality Assurance, Engineering.

• Medical device knowledge and experience.

We Offer

We offer a competitive salary and benefits package to all our employees:

• Flexible working environment

• Annual Incentive Plan % depending on company results.

• Pension scheme and group discount on healthcare insurances

• Training possibilities via Cornerstone/Harvard Manage Monitor/Skills Lab

• Employee Assistance Program and Recognize! (our global recognition program)

Our Commitment

Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact. Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.

About Medtronic

Bold thinking. Bolder actions. We are 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. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.

In everything we do, we are engineering the extraordinary.

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#LI-Hybrid

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.