Principal R&D Engineer
MedtronicAbout the role
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
As a member of the R&D Mechanical Engineering group in the Diabetes Business Unit, the individual selected for this role will be responsible for sustaining commercial products and process of diabetes related products such as insulin pumps, glucose sensors, and smart insulin pens. The Principal R&D Engineer will also strongly influence technology and process development for new products and support design transfer activities to contract manufacturers for commercial launch. The individual will leverage strong knowledge of medical device regulations and experience with quality management systems to drive successful outcomes.The ideal candidate for this position has experience in medical device design, process development, and characterization testing and has a strong background in Design Controls. In addition, the Principal R&D Engineer has driven Design Reviews, inclusive of both New Product Introduction (NPI) and Design Changes for commercial products, and has maintained Design History Files (DHF). This individual has experience in medical plastics and electromechanical assemblies. The ideal candidate has a background in process qualifications including Test Method Validation (TMV) and Design Verification Testing (DVT). This individual is experienced in performing data analysis using statistical methods and tools (DOE, Capability Analysis, GR&R). This position will work across the organization driving and collaborating with functions in Operations, Quality and Regulatory to assure the successful execution of business goals.
The person filling this role will become part of a dynamic and fast-paced R&D group with a strong history of successful product development. As a member of the R&D Mechanical Engineering group in the Diabetes Business Unit, the individual selected for this role will be responsible for sustaining commercial products and process of diabetes related products such as insulin pumps, glucose sensors, and smart insulin pens. The Principal R&D Engineer will also strongly influence technology and process development for new products and support design transfer activities to contract manufacturers for commercial launch. The individual will leverage strong knowledge of medical device regulations and experience with quality management systems to drive successful outcomes.
The ideal candidate for this position has experience in medical device design, process development, and characterization testing and has a strong background in Design Controls. In addition, the Principal R&D Engineer has driven Design Reviews, inclusive of both New Product Introduction (NPI) and Design Changes for commercial products, and has maintained Design History Files (DHF). This individual has experience in medical plastics and electromechanical assemblies. The ideal candidate has a background in process qualifications including Test Method Validation (TMV) and Design Verification Testing (DVT). This individual is experienced in performing data analysis using statistical methods and tools (DOE, Capability Analysis, GR&R). This position will work across the organization driving and collaborating with functions in Operations, Quality and Regulatory to assure the successful execution of business goals.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Responsibilities may include the following and other duties may be assigned.
- Works closely with strategic partners and vendors to support current products and initiate new production projects and assist in developing processes/techniques to meet contract objectives.
- Lead technical communications with internal and external stakeholders in support of process improvements and associated design changes.
- Perform product and process development activities of diabetes management products, including creating plans and reports and routing for approvals in an eDMS.
- Understanding of medical device design control process; le
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