Sr. Hardware Design Assurance Engineer Pre-Market Quality
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 related duties as assigned.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor’s Degree in Engineering or Science with 4+ years of work experience in Quality and/or Engineering
OR
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.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.
The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
