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

Principal Hardware Design Assurance Engineer, Pre-Market Quality supporting diabetes products.

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.
Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.

As a Principal Hardware Design Assurance Engineer in the pre-market Quality organization, you shall serve as a subject matter expert by leading and providing quality engineering support for the design & development of new product development programs that spans from hardware design, electromechanical interface, systems engineering support, and process development. The ideal candidate will act as a subject matter expert and provide guidance to the program/business in interpreting and executing against the business unit’s quality system elements.

This individual shall ensure adequate support for all hardware design work products pertaining to design control are met (e.g. Design Inputs & Design Outputs and documentation required cradle the product design through each designated design phase gates alongside program management, including DV&V). Within the design control framework, the candidate shall lead efforts developing deliverables for risk management. Additional support for engineering outputs includes, but not limited to engineering test plans/ reports, requirement documentation & traceability, engineering test methods and test result review.

The candidate is expected to understand design transfer principals to support prototype manufacturing (pilot and scale-up) in collaboration with process development Subject Matter Experts assigned to the program. The candidate shall apply engineering support to ensure development of the manufacturing process meets the established requirements of the product design meanwhile complying to Medtronic’s quality, reliability requirements.

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 Design & Development, Operations, Quality and Regulatory to assure the successful execution of business goals.

A Day in the Life

• Coordinates quality decisions between different quality and engineering counterparts.  Effectively navigates & facilitates project teams with respect to enterprise and BU’s processes and procedures ensuring the delivery of a safe and effective product design.

• Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.

• Facilitation & execution of design & process risk management deliverables by facilitating and generating product design failure modes effects analysis (dFMEA), Hazard Risk Analysis Documents (RAD), and associated deliverables like process failure mode effect analysis (pFMEA).

• Lead product design & development activities for a complex medical device product development program by effective utilization of dFMEA structure to identify key inputs, outputs, & related design controls.

• Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, GR&R etc., to inform design decision making and conclusions for deliverables like test method validations, process characterizations and verification, process validation and reliability demonstration activities

• Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and in-house Standards.

• Participates on project teams, technical review & design review activities. Leads design change control evaluations.

• Travel to vendor locations and manufacturing sites as needed to help ensure programs meeting deadlines and