Sr. Prin Project Test Lead Engineer - Product Design Verification & Reliability Engineering

Careers That Change Lives 

In this exciting role as a Sr. Principal Project Test Lead Engineer in the product design verification and reliability engineering group of the Mechanical Engineering department, you will serve as test engineering lead by and be responsible for being the voice of product test engineering as it pertains to design verification and reliability test strategy for the new product development programs. You are one of the few recognized design verification and reliability subject matter experts at your company. You will be leveraging your broad knowledge and experience crafting product design verification and reliability strategy at Diabetes, working with senior leaders in the Research and Development and program management organizations to move the bar for product test and design for reliability. As the premier engineer with a strong depth of knowledge in new product development, test, and reliability, you will be responsible for planning, scheduling, and increasing the rigor of technical product development, provide technical guidance to all test product development and test engineering counterparts and Reliability engineers within the division. You will also use your influence as a pivotal agent for change to improve product verification and reliability practices during design and development, resulting in products with significant higher quality and reliability than their predecessors. This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality, reliability, and compliance requirements. You will be involved in planning and overseeing design and reliability characterization and verification efforts on all major development programs. You will also be a strong partner with the post-market team to build a robust process for a feedback loop between the field and development especially around risk management processes. You have strong people skills and can build bridges. Most of all, you are resilient. You demonstrate persistence and patience every day in working with others to change the culture and behaviors during design and development. This individual has experience managing projects of medium to high levels of complexity through the various phases of the project lifecycle: definition, planning, feasibility, execution, and delivery. This individual is responsible for creating and maintaining schedules, budgets, and test observation risk trackers, providing feedback to the engineering team, working with vendors, contract manufacturers, and cross-functional partners through technical issues, and collaborating across the matrix within the organization.

 

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

• Negotiates within the business to improve overall product design and reliability test outcomes through increased standards and accountability.    
• As a new product development core team member, serve the program(s), extended product test counterparts, external vendors, and contract manufacturers as the primary point of contact representing the product test engineering department. Coordinate and oversee product testing activities across use life reliability testing, design verification, standards-based testing etc. within Medtronic facilities and at the vendor/contract manufacturer
• Leads large and complex medical device product development program 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 / combination products, embedded firmware, and machine learning algorithms, mobile applications, and cloud-based software applications.
• Define design for reliability (DfR) strategy and work with product development, reliability and design verification engineering counterparts for baseline reliability prediction, design characterization test planning, development, and reliability modeling and reliability demonstration.
• Partners with design and process development and quality counterparts to understand key interdependencies around design and process development maturity and lay out design freeze requirements; lead product design test readiness and outcomes review based on these assessments.
• Design verification and reliability demonstration – Understands and applies Design Verification methods & principles for developing product design verification and reliability test strategies.  Participates and collaborates with test engineers in the development, modification and design review of Protocols, Data Summaries & Record
• Partner and review risk management deliverables like design and process failure modes effects analysis (DFMEA/PFMEA) and Hazard Analysis
• Applies technical knowledge and experience to help engineering teams make choices that lead to more reliable products, earlier on in the design and development process.
• 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.
• Collaborating with the various product development teams like R&D, Ops, Design / Supplier quality, risk management etc. to ensure work products comply with Medtronic procedures, acceptable qualitative and quantitative criteria, and global standards and regulations.
• Implements and oversees design or test methods and statistical analysis procedures for achieving required levels of design rigor, product quality and reliability evaluations.
• 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, design verification, and reliability analysis and demonstration activities.
• 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 to understand test scope and impact. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.
• Leading CAPA projects and assisting post market analysis as required.
• Lead external and internal regulatory audits and inspections as it pertains to design and development testing and sustaining
• Driving Process improvement activities.
• Work under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated.
• Performs other related duties as assigned.