Careers That Change Lives

In this exciting role as a Senior Test 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. 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 writing verification test plans and 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.

DIABETES

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.

A Day in the Life

• 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 design verification and 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 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, process validation 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 analysis.

• Participating in support of external and internal regulatory audits and inspections as applicable.

• Driving Process improvement activities.

• Performs other related duties as assigned.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

Bachelor’s degree in engineering or science with 4+ years of work experience in medical device development and/or design quality

OR

Master’s Degree in Engineering or Science with 2+ years of work experience in medical device development and/or design quality.

Nice to Have

• Experience working in a regulated industry (e.g., FDA-regulated)

• Master’s Degree in Engineering, Quality, Regulatory, or related.

• Working knowledge of electromechanical medical devices with embedded firmware and systems with mobile and cloud applications

• Experienced with statistical analysis of data (e.g., MiniTab, Weibull ++, etc.)

• Experience with DFMEA, Accelerated Life Testing, Risk Analysis, Reliability Growth, and/or Demonstration Testing

• Ability to track multiple tasks and projects and create custom dashboards to engage the team, identify gaps and opportunities, and report progress.

• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, IEC 62304, IEC 60601-1, MDD & EU MDR.

• Experience in Design-Reliability-Manufacturing (DRM) or equivalent corporate design and/or manufacturing process improvement initiative

• Experience with leading large, complex initiatives of strategic importance to the business unit, involving large cross-functional teams

• Project experience in hardware testing practices, methodologies, and techniques, particularly in testing medical devices is a plus

• Ability to author technical reports, business correspondence and standard operating procedures.

• Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements

• FDA regulatory experience- e.g., presenting during FDA audits, responding to regulatory inquiries, communicating directly with FDA statisticians

• Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.

• Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.

• Self-Starter with a sharp focus on quality and customer experience

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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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. Learn more about our benefits here .

This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 here .

The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

Min Salary

95600

Max Salary

143400

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.