Sr Sourcing Engineer

Careers that Change Lives
Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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.  Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwid

The Senior Sourcing Engineer provides leadership and sourcing support for sustaining and improving projects in Post Market. The individual will act as a subject matter expert and provide guidance to the business and the external suppliers in executing against Medtronic Quality system elements as required to ensure compliance. 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 and compliance requirements. This individual will ensure Sourcing-driven initiatives meet objectives in delivering low-cost and sustainable solutions with the highest quality by supporting tools and processes at the supplier.  This role is focused primarily in the Contract Manufacturing and OEM space for Medtronic’s Active Implantables and Pumps Operations Network.

A Day in the Life: 

• Your top responsibility is for the quality of our products which support the monitoring and follow up of patients with implanted cardiac devices.
• You are a self-motivated person, determined to succeed. 
• You have strong analytical and conceptual thinking, working through the details while seeing the big picture. 
• You have a desire to learn and improve the current technology and processes, driving for creative solutions, lower cost alternatives, and sustainable results.
• You understand the importance of product performance, functions, and product use environments to appropriately and strategically apply technical knowledge to drive the suppliers Manufacturing requirements and improvements.
• You will manage projects related to continuous improvement at the supplier to ensure we have industry-leading practices.
• You will identify new opportunities through various problem-solving methodologies.
• You work collaboratively with Design Engineering, Development, Test Engineering, Regulatory Affairs, and other cross-functional partners.
• You lead process improvement projects and develop shared best practices to drive functional excellence.

Responsibilities:

• Understands therapy (clinical) performance, disease states, product function(s), and product use conditions to appropriately and strategically apply supplier selection, development, component and finished product qualification and production control plans.
• Define supplier objectives, Design and Manufacturing requirements, partner with suppliers to ensure components are designed and manufactured for reliability, manufacturability, and cost reduction via component and finished product specifications. Ensure supplier feedback is included in the development process.
• Previous Medical Device Manufacturing experience is preferred with proven abilities to establish, communicate, implement and execute on Remediation initiatives to ensure the Mfg. meets the Regulation and Medtronic requirements for Compliance and Patient safety. 
• Define product qualification strategy, partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Author or review key component and Finished good engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities.
• Drive supplier requirements and supplier performance objectives by collaborating effectively with Design, Development Engineering, Technical Sourcing, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs.
• Ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness. Resolve components/material failures and focus actions on the root cause.  Assure compliance to procedures and timely completion of CAPAs and audit findings.
• Responsibilities include Project Management and leading cross-functional improvement initiative teams, leading Design for Manufacturability and Assembly (DFMA) thinking and work practices to demonstrate functional excellence.
• Understanding of Manufacturing Process: advantages/disadvantage of various manufacturing methods for different commodity types, manufacturability, assembly, relation to design specifications, up and down requirements flow, traceability, and process control
• Ability to interpret and contribute towards Engineering Process: design intent, risk management, therapeutic & design functionality, develop qualify & implement controls
• Class II and III medical devices and regulations to include ISO13485, ISO9001 and FDA CFR.
• Utilizing development protocols including Installation Qualification (IQ), Operational Qualification (OQ), a Performance Qualification (PQ), Special Process Validations, and Test Method Validations (TMV).