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Principal Reliability Engineer (Plymouth, MN or Santa Rosa, CA)

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Engineering
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210006EJ Requisition #

Principal Reliability Engineer
Santa Rosa, CA or Plymouth, MN
210006EJ

Careers that Change Lives

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.

At our world leading Research & Development Department in Medtronic, plc, we focus on the development of cutting-edge medical devices in the Cardiac and Vascular space. Our Engineers are directly involved in the development of innovative products for use in medical procedures. The Principal Design Assurance Engineer provides design assurance engineering leadership and will fulfill the role of Quality Core Team Member (QCTM) on key programs in new product development for Peripheral products.  This includes managing extended team representing the following sub functions within QA:

DAE, Mfg. QE, Component Engineering, Receiving Inspection, Sterilization/ Microbiology, PxM, Supplier Quality Engineering, Configuration Management, Test Labs. Work is accomplished through matrixed employees/teams who are not direct reports but for which the incumbent has direct accountability to lead and achieve program objectives.

Peripheral and Endovenous therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.

A DAY IN THE LIFE OF:

  • Represent, lead, and is accountable for the functional group on the Core Team and is an integral participant in the planning and execution of the project(s).
  • Can process requirements from multiple quality sub-function stakeholders and represent in decision making process.
  • Project-manage functional tasks and deliverables per the project plan
  • Proactively identify and manage project dependencies and risks. 
  • Helps establish program objectives, timelines, milestones, and budgets.
  • Provide input to functional manager on extended team member performance and development.
  • Apply knowledge of design control principles and quality engineering techniques throughout the product development process. 
  • Identify and manage risk using a FMEA and/or other risk management tools.
  • Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
  • Establish verification and validation strategies with R&D and Regulatory to assure an efficient approval path.
  • Develop master test plans that encompass design verification, design validation and process validation activities that are sufficient to meet regulatory requirements and quality objectives.
  • Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
  • Apply understanding of anatomy & physiology with engineering knowledge in materials and processes to come up with designs.
  • Interface effectively and build relationships with team members, other staff and key technology and component suppliers, both locally and globally.

Responsibilities may also include the following and other duties may be assigned.

  • Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • 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.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
Must Have: Minimum Requirements
Bachelor’s degree in Engineering, Science or Technical Field with 7+ years of experience in Quality and/or Engineering OR Advanced degree in Engineering, Science or Technical Field with 5+ years of experience in Quality and/or Engineering.  

Nice to Have
  • Bachelor’s degree in Mechanical, Biomedical Engineer
  • High level of enthusiasm and motivation, and the ability to take input from others are desirable.
  • Dynamic team player and can work effectively and proactively on cross-functional teams.
  • Collaborate across organizational boundaries and take appropriate actions when problems occur.
  • You are an experienced professional in engineering development with extensive engineering knowledge and skills in some or all of the following: risk management, component and system design, materials (polymers and metals), sterilization of medical devices, test method development, design for six sigma principles, pre-clinical evaluations, physician interactions, knowledge of anatomical use conditions (anatomy, physiology etc.), system requirements development, design control, application of ISO standards for medical devices.
  • You are a good communicator and fluent in English, both in writing and speaking

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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Travel up 25%

 

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