Quality Core Team Member - Engineering Program Manager

In this exciting role as a Hardware Engineering Program Manager – Quality Core Team Member you will have responsibility for being the focal point of Quality for Medtronic product and system development programs in the Diabetes business. You will be a core team member leading and representing the Quality function to reach the highest level of quality and clinical outcomes for these products. These products are the key vehicles that the Diabetes business uses to deliver on the Medtronic mission to alleviate pain, restore health, and extend life. This role will plan all quality deliverables, activities, resources, application of a rigorous approach in design, manufacturability, and reliability, and be the voice of quality throughout the development lifecycle.

Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.

• Ensure internal Design Control policies and procedures comply with regulations and external standards, including hardware regulations, risk management, and change control.
• Drive product delivery across multiple programs and oversee results of remote teams who must work closely and collaboratively with your US-based engineers.
• Understanding and anticipating core team needs in terms of resources and timelines, aligning with functional managers and quality core team members to deploy appropriate resources to a program.
• Collaborate and develop FMEA and System Hazard Analysis to help drive good designs at early development stages.
• Communicate key program information to Core Team & Quality Leadership to ensure engagement and alignment, including exceptions, roadblocks, key decisions related to design trade-offs, risk-benefit and performance to key metrics and compliance. Build a culture of quality and engineering rigors spanning the hardware engineering life cycle.
• Grow process maturity and establish quality metrics in conjunction with R&D management to meet customer expectations, reliability, and system performance.
• Lead and mentor our hardware engineering group to achieve strong organizational performance, grow and manage individual talent, and advance our technology strategy.
• Serves as a primary focal point and contact for all quality aspects of a project. Represents and make decisions on behalf of quality on the core team.
• Drive establishment of Quality, Reliability, and product development strategies to improve safety, reliability, and usability of the product family for our patients.
• Maintains alignment and manages execution across all Global Quality disciplines.
• Provide leadership and guidance to create consistency in our architecture, interface, and designs that will enable platforms and future product expansion.
• Collaborate with R&D, system engineering, our product management organization and partner engineering teams in making product design decisions.
• Driving development of test strategies for complex systems, partnering with regulatory on strategies for emerging technology.
• Participate and support external regulatory audits and inspections.
• Analyze, diagnose, and resolve customer problem reports, working closely with product support.
• Ensuring that design issues found are being adequately addressed by the appropriate stakeholders for that issue through technical reviews, or through design reviews if those are more appropriate.
• Understands real-world and clinical diabetes solutions and navigates and uses data from continuous glucose monitoring systems and insulin pumps.
• Establish metrics that provide “management by data” for multiple projects running in parallel.