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Principal Design Assurance Engineer - Pre-Market Quality

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Principal Design Assurance Engineer - Pre-Market Quality


Northridge, California, United States

Requisition #:


Post Date:

Mar 24, 2022

**PrincipalDesign Assurance Engineer Pre-market Quality**

**Northridge, CA or Remote within the US with expectation to travel to site 25% of the time**

**Careers That Change Lives**

In this exciting role as a Principal Design Assurance Engineer 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 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 Medtronics 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.


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. Were 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 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 programs 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 RD, 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 and component engineering qualification activities.

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. Coordinates 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.

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**

+ Bachelors Degree in Engineering, Science or technical field with 7+ years of work experience in Quality and/or Engineering OR Advanced Degree in Engineering,Science or technical field with 5+ years of work experience in Quality and/or Engineering.

**Nice to Have (Preferred Qualifications)**

+ Experience working in a regulated industry (e.g., FDA-regulated)

+ Masters Degree in Engineering, Quality, Regulatory, or related.

+ Working knowledge of electromechanical medical devices with embedded firmware and systems with mobile and cloud applications

+ Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, MDD EU MDR.

+ Project experience in hardware testing practices, methodologies and techniques, particularly in testing medical devices is a plus

+ 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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

**Physical Job Requirements**

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life 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.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2022-03-29 Expires: 2022-06-05
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