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Engineering
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2200016C Requisition #

Careers that Change Lives: 
Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. 

The Senior R and D Engineer will contribute to the development and improvement of therapy delivery systems. Develop design concepts/prototypes/test methodology to conduct material, component, and device level testing to meet development and regulatory requirements. Document design in accordance with applicable Design Control, Quality and Regulatory requirements.  Conduct design verification and validation testing per approved protocols and document in accordance with applicable development regulatory requirements. Collaborate with design colleagues to ensure designs are capable of meeting performance targets. Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies. Support multiple projects within the Development group.
A Day in the Life: 
• Work with cross-functional teams to develop and maintain Design History Files (DHF) for combination devices. 
• Understand Customer needs/requirements and translate into product specifications. 
• Develop and execute Design Verification and Design Validation studies to evaluate new products or changes to existing designs.
• Support Design Transfer activities and work collaboratively with manufacturing to evaluate the impact of process changes on the product design. 
• Contribute to Risk Assessment and Failure Mode Effects Analysis (FMEA) documents. 
• Have a working understanding of design control procedures, 510(k) submissions, and standards related to combination devices. 
• Use data-driven problem solving to resolve issues that arise and prevent reoccurrence.
• Design and execute experiments optimize the process predictability and improve yields
• Work on identifying next generation products by working with marketing and cross functional business units. 

 

Must Have: Minimum Requirements
 
  • Bachelors degree required
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience or a PhD
Nice to Have: 
•B.S., M.S. or PhD in a relevant engineering field, preferably Biomedical Engineering, Mechanical Engineering, or Chemical/Pharmaceutical Engineering field
•Experience in medical device industry with focus in product development
•Knowledge of basic material characterization techniques, including mechanical and analytical.
•Knowledge of the product development process.
•PC experience (MS Word, Excel, PowerPoint, MS Project, etc.).
• Advanced degree in Biomedical, Chemical or Pharmaceutical Engineering 
• Six Sigma Green Belt or Black Belt certification 
• Experience with combination products. 
• Understanding of animal models required for preclinical research. 
• Working knowledge and understanding of Polymer Science & Engineering, along with analytical techniques. 

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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