Quality Engineer II

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 In this exciting role as a Quality Medical Writer in Medtronic s Surveillance process within the quality and clinical organizations, the incumbent will contribute to the Post Market Surveillance, Post Market Clinical Follow-up and Clinical Evaluation document writing process to ensure compliance to regulations and expectations of Regulatory Bodies. This is a scientific (engineering, technical, medical) writing position. This individual will partner with other teams such as Quality/Reliability, Clinical Research, Regulatory Affairs, Product Development, Medical Safety, and Statisticians to collaborate and execute tasks in a timely manner.

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

• Contributes to portions of Post Market Surveillance, Post Market Clinical Follow-up and Clinical Evaluation plans and report documents that are authored by operating unit employee.
• Interface with Clinical and Post Market surveillance operating unit employees to obtain necessary information to complete tasks.
• Develop therapy and product knowledge and apply this knowledge to surveillance of products.
• May participate meetings to meet objectives.
• Provide input and feedback to ensure clear, concise complete reports.
• Collaborate with cross-functional team to assure high quality and successful completion of deliverables
• Report on schedule, timelines and deliverables
• Collect safety communications and compile reports
• Collect CAPA, FCA and IIA information and compile reports
• Review of key data elements to ensure no changes and consistency across various reports.
• Contribute or participate in drafting responses to deficiencies from regulatory agencies.
• Compiles, analyzes, and summarizes literature and additional data from other sources as needed.
• May participate in review activities and approval of other documents authored by another function

Required Knowledge and Experience

• Detail oriented
• Bachelor s Degree in Engineering, Science, medical or technical field with 2+ years of work experience in Medical Writing, Engineering and/or Quality.
• Knowledge and apply this knowledge to post market surveillance of products.
• Medical device experience; or experience in a regulated environment
• Ability to identify customer/stakeholder requirements, and constructively respond to feedback/comments/inquiries
• Analyzes complex issues and significantly improves, changes, or adapts existing methods.
• Ability to work with very little direction towards predetermined long-range goals and objectives. `
• Proficient knowledge and understanding of medical terminology, clinical practices, physiology and/or applicable disease states, Neuromodulation therapies and technologies
• Ability to achieve objectives and milestones through identification and implementation of work plans and measurements.
• Ability to identify and adapt to shifting priorities and competing demands
• Knowledge and understanding of Good Clinical Practices, Post Market Surveillance, EU MDR Regulation, Quality Management Systems, Risk Management and other regulatory standards

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