Careers That Change Lives 

In this exciting role as a Senior Design Quality Engineer – Process Development in the Pre-Market Hardware Quality organization, you will serve as a subject matter expert by leading and providing process development quality support for the new product development programs ranging across electromechanical device manufacturing and sensor fabrication processes. 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/system work products to ensure compliance. This individual will ensure that all system-level project / program work products as it pertains to risk management and process development / validations (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality, reliability, and compliance requirements. The ideal candidate has a strong background in process design, development and qualification including Test Method Validation (TMV) and design transfer.This individual is experienced in performing data analysis using statistical methods and tools (DOE, Capability Analysis, GR&R). This position will work across the organization driving and collaborating with functions in Design & Development, Operations, Quality and Regulatory to assure the successful execution of business goals.

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.comto see an overview of the products in our Diabetes product portfolio.

A Day in the Life

• Drive risk management deliverables by facilitating and generating process failure modes effects analysis (PFMEA) and Hazard Analysis and experienced in facilitation / execution of the process FMEAs
• Lead process development activities for large and complex medical device product development programs by effective utilization of PFMEA structure to identify key process inputs, outputs, control as well noise factors
• Collaborate with product and process development teams to develop P-diagram/ Input-Process- Output (IPO) matrices, process characterizations, test methods and process validation strategies (IQs/OQs/PQs and TMVs) for new products in development
• Ensure essential design outputs / critical to quality (CTQ) attributes are traced down to manufacturing process output specifications and controlled in manufacturing processes by partnering with appropriate design and operations team members in early design and development
• Generate master validation plans/reports and design transfer activities as applicable
• Play a hands-on role in design transfer planning and ensure development projects are transitioned to manufacturing facilities – play a key role if defining success KPIs, design specifications to process output specification flow down, manufacturing process development & qualification for transitioning development projects to manufacturing across multiple Medtronic sites and quality systems.
• Travel to vendor locations and manufacturing sites as needed to help ensure programs meeting deadlines and troubleshoot issues.
• Apply methodologies such as Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA) and Cell Operating System (COS) during process design and development phase
• Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, GR&R etc., to inform decision design decision making and conclusions for deliverables like test method validations, process characterizations and verification, process validation and reliability demonstration activities
• Assisting Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities.
• Understands the interdependencies of FDA design controls and production and process controls and ensure processes are developed with the right level of control and maturity to deliver products for design verification testing and design validation studies
• Design Verification/Validation and Reliability demonstration – Understands and applies basic Design Verification/Validation methods & principles for developing design verification, validation, and reliability test strategies. Participates and collaborates with test engineers in the development, modification and design review of Protocols, Data Summaries & Record
• Collaborate 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
• 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.
• Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in support of the deployment of the different operating unit (OU) strategies and products.
• Leading CAPA projects and assisting post market analysis.
• Participating in support of external and internal regulatory audits and inspections.
• Driving operating procedures / process improvement activities.
• Performs other related duties as assigned.