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

Medtronic

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Our Purpose

In our Structural Heart Post Market Quality Department, we focus on completing investigations for complaints and returned devices, periodic trending of complaint data, evaluating negative trends and assess risk to released products which aids in determining appropriate field actions.

We partner with cross functional teams perform thorough complaint investigation, and with regulatory and customer quality experience management to prepares appropriate responses to regulatory queries for product registrations and other regulatory submissions. The department owns and maintains periodic safety update report (PSUR) by collaborating with several cross-functional teams for applicable devices.

Come for a job, stay for a career!

A Day in The Life Of:
In general, the following responsibilities apply for the Quality Engineer I. This includes, but is not limited to the following:

• Leads complaint investigations, conducts periodic trending of complaint data, evaluates negative trends, assesses risk to released products which aids in determining appropriate field actions.
• Collaborates with cross functional teams like customer quality experience management, clinical affairs, medical safety, R&D engineering and manufacturing to perform thorough complaint investigation.
• Prepares appropriate responses to regulatory queries for product registrations and other regulatory submissions by working with the regulatory affairs team.
• Partners with design assurance team on risk analysis of new products by reviewing files such as product hazard analysis, DFMECA, post market surveillance plan, risk management report, etc.
• Develops solutions to unique issues with wide range of difficulty. Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation across functions and/or businesses which may cause redirection.
• Prioritize timely presentation of quality issues and escalate to leadership based on sound engineering, analysis & review for the success of the business.

Key Skills & Experience

• Minimum of Level 7 bachelor’s degree required in Mechanical, Mechatronics, Manufacturing, Electronics & Biomedical Engineering or related discipline preferred.
• Minimum of 1-year relevant direct Science/Engineering experience within medical device environment.
• Candidate must be a dynamic team player and can work effectively and proactively on cross-functional teams.
• Candidate must be able to think critically and make sound decisions
• Demonstrated understanding of cardiovascular/implant procedures is an advantage
• Experience in a highly regulated industry, preferably implantable medical devices is an advantage
• Knowledge of product development cycles including clinical and regulatory requirements is an advantage
• Experience in Complaint handling or risk management would also be desirable.

Medtronic offer a competitive salary and flexible Benefits Package

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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.
 

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

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 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.

Learn more about our business, mission, and our commitment to diversity here