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1+ months

Principal Reliability Engineer

Santa Rosa, CA 95404
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Principal Reliability Engineer


Santa Rosa, California, United States

Requisition #:


Post Date:

Nov 20, 2020

**Careers that Change Lives**

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

position offers the exciting opportunity to join the successful Aortic,
Peripheral and Vascular (APV) Business Unit as a Principal Quality Engineer.

position encompasses QA and technical support of the franchise value stream
products, leading creative improvement initiatives, project management,
coaching and global cross functional collaboration.


all aspects of quality product management for commercially released products.
This includes but is not limited to monitoring product field performance, addressing
identified trends, technical and risk management-based product analysis, leading
consequent clinical impact to recommend any necessary corrective field actions.

cross-functional teams to investigate field reported quality events. Presents
overall field performance trends, clinical outcomes and device failures to the
rest of the organization as input to improve product design or manufacturing

the initiation and executions of system level improvement plans across a
variety of areas, using Lean principles, to increase efficiency, reduce cost
and streamline operations. Leads or participates
in other sustaining engineering projects or initiatives.

Regulatory Affairs by providing quality input for notified body submissions or
follow up queries.

excellent technical writing when authoring assigned Product Risk Assessment,
Health Hazard Analyses, Post-Market Surveillance Reports. Facilitates Design
FMEA and Risk Management File updates on assigned product lines.

or owns in corrective/preventive action teams to resolve systemic issues. Partners
with cross-functional peers to resolve product performance issues (NCMRs, CAPAs,
deviations, manufacturing process problems etc.) to assess impact on device
quality and product availability.

with multiple manufacturing sites and external suppliers to review and assess
any design or process changes that may impact the product specifications or
overall performance. Helps create qualification strategies to implement complex

peers in the organization and helps facilitate technical and professional
development of others.

**Must Have: Minimum Requirements**

Bachelors Degree in Engineering, Science, or other Technical Discipline

7+ years (with Bachelor's) or 5+ years (with Master's) of industry
experience in Engineering, Science, or other technical discipline

**Nice to Have**

Experience in a
highly-regulated industry, preferably implantable medical devices

Knowledge and experience in
application of statistics and lean sigma principles

Knowledge of cardiac anatomy,
physiology, and primary disease states

Working knowledge of 21 CFR
Part 820 (Quality System Regulation), ISO 13485, EU Medical Device Directive
and relevant international standards.

Experience in the application
of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques
(e.g., PHA, DFMEA)

Demonstrated ability to work in
a matrix organization and positively influence strategy and outcomes

Ability to deliver on multiple
projects simultaneously, and balance between long- and short-term priorities

Demonstrated critical thinking
skills with focus on improved system performance outcomes and positive business

Excellent problem-solving
skills, including demonstrated application of structured problem-solving
methods and tools

Strong written and oral
communication skills (timely, clear, concise, accurate, conclusive,
influential, targeted to audience)

Strong collaboration and
influence skills (build relationships, leverage others, align and work towards
shared outcome-based goals, understand others needs, negotiate for win-win,
own the whole)

**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 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)
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: 2020-11-24 Expires: 2021-03-01
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Principal Reliability Engineer

Santa Rosa, CA 95404

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