In this role, you have the opportunity to
Support New Product Development projects within Image Guide Therapy with respect to software, firmware, and hardware from a design quality assurance perspective.
You are responsible for
Lead and support the creation and review of risk management file to include the risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination.
Ensuring Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software.
Support in the creation and review of all medical device documentation including cyber security assessments such as Data Protection, Privacy, and Security Assessments etc.
Understanding of all aspects of the QMS related to Design Controls. 21 CFR 820, ISO 13485
Development and status reporting of Quality and Reliability metric during phase reviews.
Participate in Design Verification Planning, Protocol Review, Report Review.
Participate in Design Validation Planning, Protocol Review, Report Review.
Participate in Process Validation Planning, Protocol Review, Report Review.
Provide Guidance on Quality aspects of PDLM Deliverables in addition to Design Verification/Validation.
You are a part of
Our solutions combine navigational tools such as catheters and guide wires with advanced software to help confirm the optimal treatment at the point of care: measurement technology, procedure-specific application support and on-board imaging and monitoring with improved anatomical and functional information to optimize therapy delivery. The IGT Devices organization consists of three segments: Coronary, Peripheral Vascular and Electrophysiology.
To succeed in this role, you should have the following skills and experience
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Engineering or related Science degree.
5+ years of quality engineering experience.
Graduate degree in Engineering/Science preferred.
Expertise in applying ISO 13485, ISO 14971, IEC 60601 and working knowledge with IEC 62304 and other relevant medical device standards.
Knowledge in manufacturing processes
Experience with medical device development lifecycle mythologies including Agile and SAFe preferred.
Familiar with systems engineering tools including software tools such as, design traceability, defect tracking and management tools such a Jira or Clearquest.
Statistical software solutions such as JMP or Minitab
Design for reliability concepts and relating complaint history to reliability goals on new projects
Strong leadership skills and ability to work in a team environment
Highly motivated hands-on engineer/scientist with a proven record of meeting timelines and goals
Must possess strong analytical & problem-solving skills
Knowledge of Non-Product Software Validation, IQ OQ PQ
In return, we offer you
We offer you the opportunity to grow within the organization and Philips – working cross functionally with R & D, on various projects and initiatives to drive our products to our customers and be a part of saving people’s lives every day.
The salary range for this position is: 95k-119k. The bonus target is: 10%
Our benefits can be found here: https://www.careers.philips.com/na/en/total-rewards-at-philips.
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. Learn more by watching this video.
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.
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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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