Quality Engineer II-Hyderabad

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 About Medtronic

We re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide. Come strengthen your specialized skills and enhance your expertise. We ll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that s best for you.
Together, we can confront the challenges that will change the face of healthcare. Join us for a career that change lives. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together. In this exciting role as reliability engineer in Cardio Vascular portfolio, you will provide key technical expertise with in the Cardiac Rhythm Management (CRM) operating unit . You will have responsibility for supporting post-market surveillance activities including analyzing product performance data, authoring risk assessments and technical reports, and support quality issue investigation/management to improve product performance for implantable products (Pacemakers, Defibrillators, and Leads). The CRM operating unit offers high power devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. A Day in the Life As a reliability engineer, you will:

• Responsibilities may include the following and other duties may be assigned.
• Provide reliability and engineering skills to analyze, debug, and as necessary propose design changes to improve system and/or process reliability.
• Execute risk analysis studies of design and processes to understand how potential quality issues may be contributing to product quality or patient safety risk.
• Prepare risk assessments and technical reports to document analysis results or quality impact.
• Provides or directs verification and validation of device system requirements, traceability, and testability.
• Conducts evaluation of finished product systems including requirements, design, development, documentation, integration, test, verification, and validation. Interpret and decompose system and product requirements, verify compliance.
• Make recommendations on risk management file updates and collaborate with the risk file owner on the execution of the updates
• Complete risk assessments related to product nonconformances and performance trends associated with product released to the field.

Required knowledge Experience:

• Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 4+ years of work experience.
• Strong communication skills, both oral and written.
• Ability to comprehend principles of engineering, physiology and medical device use.
• Comfortable working with international and multi-cultural department and groups in different time zones.
• Experience in risk management or reliability engineering
• Accurate and delivers quality work, with a sense of urgency.

Skill-set nice to have:

• Good interpersonal skills.
• Experience in root cause investigations and assessing risk impact of proposed design changes
• Experience supporting production electrical test requirements and development of manufacturing electrical test applications.
• Experience with 21CFR820, ISO13485, and ISO14971
• Experience with design, verification, and validation of Class III medical devices or similar regulated product
• Demonstrated ability to perform data analysis using statistical techniques and reliability tools.
• Ability to work effectively in a team environment and build strong working relationships.
• ASQ certification - CQE,CRE
• Lean Six Sigma certification .

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.

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.

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 90,000+ passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD 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