We anticipate the application window for this opening will close on - 9 Jul 2025

 

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

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.

In this exciting role as a Senior Reliability Engineer in the in the product design verification & reliability engineering group of the Mechanical Engineering department, you will be responsible for product verification and reliability test planning/ designing, developing, and implementing testing methods and equipment for new product development and sustaining projects relating to infusion pump systems. The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Medtronic quality system elements including hardware product verification & reliability test related work products to ensure compliance. Provides test area with parameters for sample testing and specifies tests to be performed. Compiles data and defines changes required in testing equipment, testing procedures, manufacturing processes, or new testing requirements. Responsible for reliability assessments and test reports. This individual will ensure that all program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality, reliability, and compliance requirements. This individual will ensure product reliability and verification driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.

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

• Plan and execute large and complex medical device product development programs design verification and reliability test strategy by collaborating and ensuring appropriate key interdependencies are understood and delivered upon by cross functional counterparts from design planning through design transfer for electromechanical hardware product development.

• Collaborate with systems engineering and product development teams and apply a systems mindset to develop and evaluate designs from a design input requirements / design outputs perspective that span across multiple product interfaces like electro-mechanical, electro-chemical sensors, embedded firmware and machine learning algorithms.

• Plan and execute product reliability demonstration – understands and applies basic product design verification methods & principles for developing design verification, and reliability test strategies.  Lead the development, modification and design review of plans, reports, protocols, data summaries & record.

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

• Partner and review risk management deliverables like design and process failure modes effects analysis (DFMEA/PFMEA) and Hazard Analysis

• Utilize the risk management and robust design principles to understand essential design outputs / critical to quality (CTQ) attributes by partnering with appropriate design team members in early design and development and develop test methodologies to demonstrate effectiveness.

• Assisting Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities as applicable

• Participates on project teams and technical review boards and leads change control evaluations. Coordinate’s quality decisions between different quality and engineering groups.  Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.

• Driving clarity and consistency in documentation.

• Leading CAPA projects and assisting post market an