Senior Reliability Engineer

Medtronic•Northridge, CA

About The Position

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 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. Click here to learn more about products. 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. 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. Negotiates within the business to improve overall product reliability through increased standards and accountability 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 analysis. Participating in support of external and internal regulatory audits and inspections as applicable. Driving Process improvement activities. Performs other related duties as assigned.

Requirements

Requires a Bachelor’s degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

Responsibilities

Negotiates within the business to improve overall product reliability through increased standards and accountability
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 analysis.
Participating in support of external and internal regulatory audits and inspections as applicable.
Driving Process improvement activities.
Performs other related duties as assigned.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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.
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)