Flexible Work Arrangement

Nanakramguda, Hyderabad, India

Full time

R78368

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 The Quality function partners with Research & Development and Operations teams to ensure medical devices are designed, developed, and maintained in compliance with applicable quality system regulations, risk management requirements, and international standards. The team provides quality engineering leadership throughout the product lifecycle, supporting design controls, verification and validation activities, risk management, product transfers, regulatory compliance, and continuous quality improvement initiatives.

This position is based in Hyderabad, India and follows a Flex work arrangement. No travel is required.

As a Quality Engineer II, you will provide design quality engineering support for medical device product development and sustaining engineering activities. The role is responsible for facilitating the application of design controls, risk management, design verification and validation, and regulatory compliance activities while partnering with cross-functional teams throughout the product lifecycle.

Primary Responsibilities

- Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.

- Ensure product development projects and design changes comply with FDA Quality System Regulations, European Union Medical Device Regulation (EU MDR), and internal quality requirements.

- Partner with cross-functional teams to develop and maintain risk management documentation, including Risk Management Plans, Hazard Analyses, Design Failure Mode and Effects Analysis (DFMEA), and Risk Management Reports in accordance with ISO 14971.

- Support design verification and validation activities through development and review of plans, protocols, reports, testing strategies, and compliance assessments.

- Review Design History Files (DHF) and Technical Files for compliance with applicable regulations, standards, and quality requirements.

- Support successful transfer of products into manufacturing through process validation activities, including Process Failure Mode and Effects Analysis (PFMEA), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

- Develop quality system templates, training materials, and guidance related to design controls, risk management, quality system regulations, and applicable standards.

- Participate in internal and external audits and provide quality engineering guidance across project teams and organizational functions.

Required Qualifications

- Bachelor's degree in Mechanical Engineering with 5 years of overall experience, including 3 years of quality engineering experience in medical device, regulated manufacturing, or healthcare industries.

- Experience with medical device Design Controls, Risk Management, and product development activities.

- Experience supporting ISO 14971 risk management activities,



including Risk Management Plans, Hazard Analyses, and Design Failure Mode and Effects Analysis (DFMEA).

- Knowledge of FDA Quality System Regulation, ISO 13485, EU MDR, IEC 60601, 21 CFR Part 820, and 21 CFR Part 11.

- Experience using statistical tools and methodologies, including Minitab, sampling plans, hypothesis testing, Analysis of Variance (ANOVA), Gauge Repeatability and Reproducibility (GR&R;), and related statistical techniques.

Preferred Qualifications

- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), or Certified Reliability Engineer (CRE) certification.

- ISO 9001 or ISO 13485 Internal Auditor or Lead Auditor certification.

- Lean Six Sigma Green Belt or Black Belt certification.

- Experience with DMAIC or Design for Six Sigma (DFSS)/DMADV methodologies.

- Experience acting as a Risk Management or Design Quality subject matter expert within cross-functional product development 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.

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.

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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 market-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.

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This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

- Build a better future, amplifying your impact on the causes that matter to you and the world

- Grow a career reflective of your passion and abilities

- Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

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📌 Quality Engineer II (Nanakaramguda)
🏢 Medtronic
📍 Nanakaramguda