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Job Information

Philips Verification & Validation Engineer in Bothell, Washington

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In this role, you have the opportunity to

Support TMV activities, CAPA remediation, and additional leadership for the V&V team.

You are responsible for

  • Developing strategy and revise test validation procedures/protocols to ensure that products are manufactured in accordance with appropriate FDA validation requirements and current industry standards

  • Providing Test Method Validation (TMV) expertise for internal teams and assisting with the design of method validation activities

  • Leading the development of test method validation strategy, sometimes working autonomously then disseminating approach throughout the organization

  • Planning and performing the execution of Measurement System Analysis such as: gage R&R, linearity and bias studies, etc…

  • Compiling and analyze validation data, prepare documentation, and make recommendations for changes and/or improvements

  • Statistical Analysis experience related to validation activities, and familiarity with Minitab is strongly preferred

  • Defining, documenting, and continuously improving verification plans and protocols including conducting peer reviews and maintaining traceability to requirements

  • Performing system verification tests and conduct analysis of the test results to ensure complete verification of the requirements, identifying, analyzing, owning and driving technical issues to resolution

  • Working closely with engineering departments to drive high quality design inputs

  • Supporting product and accessory verification through development, manufacturing and into production

  • Participating in reviews of requirements, design documents, and test related artifacts

  • Mentoring, coaching, and providing work direction to other engineers, technicians and interns

  • Proactively owning and driving process improvements

  • Working independently on tasks as subject-matter expert and report progress

You are a part of

The Philips ECR (Emergency Care & Resuscitation) Division where you will be directly on the Automatic External Defibrillator (AED) V&V team to provide support for sustaining activities.

To succeed in this role, you should have the following skills and experience

  • 5+ years’ industry experience in a product development environment required with a Bachelors or Master degree in Electrical, Mechanical, bio-Engineering, Chemical or other similar engineering degree.

  • 3+ years of experience specific to Test Method Validation, IQ, OQ, PQ, or related activities

  • Experience in a class III medical device preferred, or other regulated industry

  • Statistical Analysis experience related to validation activities, and familiarity with Minitab is strongly preferred

  • Familiarity with medical device regulations such as 21 CFR 820, 13485, EU MDR

  • Working with Standards such as ISO 14971, IEC 62366, IEC 60601-xx, IEC 62304 is preferred

  • Understanding of risk analysis and risk-based decisions with regard to designing and executing tests

  • Excellent written and verbal communication skills required

  • Strong attention to detail and Proven ability to perform problem solving and troubleshooting

  • Proficiency in using typical lab equipment (e.g. oscilloscopes, signal generators, spectrum analyzers, voltmeters, etc.)

  • Must be self-motivated and able to work in a fast paced, team-oriented environment

  • Knowledge of IQ, OQ and PQ activities in a manufacturing environment

  • Ability to work with minimal guidance to make decisions and report progress

  • Demonstrated leadership role in test and issue ownership including ability to provide guidance and direction to less experienced technical personnel

  • Experience with requirements management, configuration management, issue tracking tools, etc.

In return, we offer you

An opportunity to design, produce, and deliver every solution as if the life of someone we love depends on it. Every day, we empower and enable our customers – from clinicians to paramedics, first responders to the every man – to save lives using our innovative, market leading technology.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

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