Senior Design Quality Engineer (Early Product Development)

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Job TitleSenior Design Quality Engineer (Early Product Development)Job Description


If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to

The Lead Quality Engineer for Early Development (Image Guided Therapies) is accountable for oversight of quality and risk management throughout the pre-productization development phase. This role ensures that products/prototypes are developed in accordance with applicable standards & regulations to facilitate transfer into (clinical) studies or further development and commercialization. In this role you will be responsible for assessing IGT Research Portfolio for risk, ensuring key initiatives are prioritized and providing independent oversight to applicable design control elements.

You are responsible for

  • Acts as single point of contact for R&D teams to ensure appropriate QMS processes are identified and implemented within the project, including identifying applicable deliverables and tailoring as appropriate
  • Identifies Quality / Regulatory requirements based on scope of development activities
  • Provide effective oversight of the execution of early design and risk management activities; including assisting teams in creation of Risk Management deliverables and reviewing or approving documentation
  • Leads Quality related problem solving efforts
  • Makes meaningful contributions to the team in combining the Agile methodology with the Quality System requirements
  • Ensures Quality is embedded within the organization by acting as a champion of best practices and by escalating quality related concerns
  • Collects and reports on Quality related key performance indicators when defined
  • Communicate with Q&R both within Research as well as in the business (where applicable) to align expectations and escalate when needed to the appropriate level in case non-compliances are not solved.
  • Provides guidance on key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
  • Act as a point of contact for multiple projects responsible to ensure that hardware design meets quality and compliance standards for every milestone

You are a part of

Philips Chief Technology Office (CTO) Quality team. Our global team provides opportunities to develop your career in a variety of ways; work on global team projects, work with key thought leaders and influencers to drive change, improve health outcomes and deliver meaningful experiences for the consumer.

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.
  • 6+ years of Quality Engineering experience in a regulated environment preferably within the Medical Device space
  • Bachelor's degree in Engineering or related field
  • Reviewing test and other performance data
  • Responsible for performing timely, quality engineering tasks like:
    • Assessing quality plans and product designs
    • Guides others to complete Quality Engineering Documents. Can develop & administers quality related project plans and schedules.
    • Analyses of risk inputs and mitigations
    • Leading root cause analysis and quality problem solving.Â
  • Mentor other team members on quality related projects or issues.
  • Familiarity with hardware, embedded software and stand-alone software quality engineering principles
  • Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
  • Experience in early product development or pre-manufacturing activities

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

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.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

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.

Equal Employment and Opportunity Employer/Disabled/Veteran




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6 days ago

Cambridge, Massachusetts


Full Time

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