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

Bring your talents to an industry leader in medical technology and healthcare solutions: Medtronic technologies transform the lives of two people every second, every hour, every day. And counting. Our engineers and scientists work in relentless pursuit of solutions that improve lives, harnessing the power of artificial intelligence, data insights and robotic-assisted surgery. We may not know what the future holds, but we are boldly attacking the most challenging health problems facing humanity, searching out and finding solutions.

We seek out and hire a diverse workforce at every level. We need fresh ideas and inclusive insights to continue to be an innovative industry leader — that’s why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. Medtronic walks the walk, creating an inclusive culture where you can thrive.

We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. To learn more, we invite you to visit www.benefits.medtronic.com

Responsibilities may include the following and other duties may be assigned:

• Monitor the medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
• Management of the continuous improvement projects, aligning cross functional resources on strategic project goals and timelines, reporting progress and project costs, developing relationships with cross OU teams to share best practices and creating a culture of success through stakeholder amangement.
• Take accountability and drive actions for Quality Key Performance Indicators.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Provide strategy and leadership to a team that handles complaints
• Provide governance and conduct operations of the team
• Provide regular updates on KPIs to the internal and external stakeholders, proactively perform risk assessment, anticipate and raise concerns in advance.
• Evaluate strategy to transform operations and look for continous improvements through lean sigma DMAIC principles.
• Interact with Service & Repair depots, Regional Quality Management systems, Enterprise CAPA specialists, Operating Unit SMEs and Compliance specialists, Sales or field representatives.
• Interact with Enterprise Process Excellence, Program Management, Quality Assurance and Global Technology teams for automation and next gen tools, as needed,
• Interacts with multiple departments within Medtronic such as Service & Repair, Product Returns, Sales, Technical Services, Failure Investigation, R & D, Manufacturing and Engineering.
• Interacts with groups external to Medtronic such as customers, vendors, health care professionals
• Perform quality assurance through quality check tools and ensure team maintains quality first.

Required Knowledge and Experience:

• Bachelor degree; Engineering or Science degrees preferred (e.g. SW,EE, ME, Biomedical Engineering)
• 15+ years quality assurance or regulatory experience in medical or pharmaceutical industry.
• Minimum 5 years of people leadership experience in handling medium to large size teams.
• Computer literate with skills in Word, Excel, Access, PowerPoint, Power BI and database trending analysis
• Strong typing skills and ability to write business documents with minimal supervision.
• Strong verbal and written communication skills and ability to work in a team oriented environment
• Ability to be proactive and lead initiatives technically
• Ability to multitask.
• Ability to understand the functionality / intended use of complex medical devices.
• Minimum travel may be required.
  Nice to Haves:
• Knowledge of medical devices, their development and quality control.
• Knowledge of FDA, MEDDEV, Canadian Regulations.
• Knowledge of Python (NLP).
• Technical Writing experience.

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.