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Principal Design Assurance Engineer 

adzuna-us  |  United States  |  

United StatesE 2nd St, null, 92701
Work Type:
Work Time:
Full Time


Careers that Change LivesIn this exciting role as a Principal Design Assurance Engineer, you will have primary focus on new product development for Structural Heart business.As a member of the Design Assurance team, you will have primary responsibility for influencing product quality and reliability outcomes across new product development projects.CVGCORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.A Day in the LifeResponsibilities may include the following and other duties may be assigned.Integral member of product development team responsible for leading activities required to ensure reliability of the design.

Work closely with product development engineering, clinical, marketing and regulatory to assure appropriate reliability requirements are defined for the specific device application and target patient population.In collaboration with product development, formalize new testing methodologies and approaches required to complete comprehensive reliability analyses of device designs.

Lead verification and validation activities for newly developed test methods.

Must be "hands on" when leading the development and validation of functional test methods.Direct completion of specific product verification/validation testing and analyses required to satisfy both regulatory and internal Medtronic requirements, including the preparation of high-quality plans and technical reports.Work directly with product development engineering to translate user requirements into design requirements down to the component level.

Provide support for the identification of critical components and design features.Leads risk management activities throughout the product life cycle, including Preliminary Hazard Analyses, DFMECAs, PFMECAs, and UFMECAs.Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability.

Provide guidance for development of manufacturing test/evaluation methods to assure process reliability requirements are attained.Serve as a technical resource for problem investigations to guide root cause analysis / corrective action development.Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.Completes risk analysis studies of new design and processes.May determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data.Must Have: Minimum RequirementsBachelor’s Degree in Engineering, Science or technical field with 7 years of work experience in Engineering and/or Quality OR Master’s Degree Engineering, Science or technical field with 5 years of work experience in Engineering and/or Quality.Nice to HaveExperience in reliability testing and analysis of implantable, life sustaining cardiovascular devicesExperience with materials traditionally used in prosthetic heart valve substitutes (e.g., bovine pericardia tissue, porcine valve tissue, titanium alloys, stainless steels, pyrolytic carbon, etc.)Experience with ISO 5840, IEC 62366, ISO 14971, ISO 13485, FDA QSREffective negotiation and influencing skillsExperience with reliability analysis and testing of safety critical devicesAbility to effectively manage multiple competing prioritiesCertified Reliability Engineer (CRE)Certified Quality Engineer (CQE)Six Sigma Black Belt (Medtronic or external)Certified Project Management (PMP)About MedtronicTogether, 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

(ADA-United States of America)