Sr. Hardware Design Quality Assurance Engineer- Combination Devices.

Careers That Change Lives

In this exciting role as a Senior Design Assurance Engineer Combination Products in the Pre-Market Hardware Quality organization, you will serve as a subject matter expert by leading and providing technical design quality support for the new drug / device combination product development programs.

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 (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 is 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

• Leading large and complex drug / device combination product development programs per the FDA design controls starting from design planning through design transfer by demonstrating a firm understanding of the design input, design outputs, risk management, design verification, design validation and design transfer processes.
• 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 products like electro-mechanical and electro-chemical sensors with drug / device interface.
• 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.
• Partner with cross functional counterparts to strategize, support and review combination product stability evaluations / design verification testing as well as product release requirements to maintain compliance with ICH and CDES Guidelines
• 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.

• 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.
• 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, supplier agreements and component engineering qualification activities as it pertains to drug products and drug substances.
• Understanding of the interdependencies of program work products and guide the teams in execution strategy and participating in development, review, and approval of all program work products (e.

g.plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).

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.
• 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.
• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.

Must Have : Minimum Requirements

Bachelor’s Degree in Engineering or Science with 4+ years of work experience in Quality and / or Engineering

Master’s Degree in Engineering or Science with 2+ years of work experience in Quality and / or Engineering.

Nice to Have

• Experience working in a regulated industry (e.g., FDA-regulated)
• Bachelor’s Degree in Biomedical, Mechanical, Chemical or Electrical preferred.
• Master’s Degree in Engineering, Quality, Regulatory, or related.
• ASQ Certification in Quality or Reliability.
• Strong understanding and hands on experience with the FDA production and process controls (P&PC), experience in planning of process validation / test method validation activities.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.
• Understanding of the interdependencies of program work products and guide the teams in execution strategy and reviewing the program work products (e.

g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).

• Experience with planning and executing design verification testing, test method development and test method validation (hands on execution experience preferred).
• Working knowledge of hardware development for medical devices.
• Ability to author technical reports, business correspondence and standard operating procedures.
• Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.
• Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
• Ability to multi-tasks, prioritize, meets / exceed deadlines and hold themselves, and others accountable.
• Self-Starter with a sharp focus on quality and customer experience.
30+ days ago