Careers That Change Lives
In this exciting role as a Senior Design Assurance Engineer in the Pre-Market Hardware Quality, you will serve as a subject matter expert by providing technical design quality support for the new product development and sustaining projects. 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 related work products 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, reliability, and compliance requirements. This individual will ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.
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
• Leading large and complex medical device product development per the FDA design controls starting from design planning through design transfer by demonstrating a firm understanding of the design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to 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, mobile applications, and cloud-based software applications
• Drive risk management deliverables by facilitating and generating design and process failure modes effects analysis (DFMEA/PFMEA) and Hazard Analysis and experienced in facilitation / execution of the process or design FMEAs.
• Utilize the risk management and robust design principles to lead development and identification of essential design outputs / critical to quality (CTQ) attributes by partnering with appropriate design team members in early design and development
• 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
• 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.
• Generating master validation plans/reports and design transfer activities as applicable
• Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform decision design decision making and conclusions for deliverables like test method validations, design characterizations and verification, process validation and reliability demonstration activities
• Assisting Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities
• 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.
• Driving Process improvement activities.
• Work under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
• Performs other re
Location: Los Angeles, CA
Posted: Aug. 21, 2024, 8:30 a.m.
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