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Philips

Senior Design Quality Engineer

San Diego, CA

Job Title
Senior Design Quality Engineer

Job Description

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees may request a reasonable accommodation. Montana employees are currently excluded from this requirement at this time.

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.

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.



But it's not just what we do, it's who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers' needs. It's what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.

The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better:

The Sr Design Quality Engineer will play a critical role in ensuring product quality, safety and compliance through design, oversight and execution of product design/sustaining activities with a primary focus in Risk Management for Philips Sleep & Respiratory Care products.

You are responsible for:
  • Responsible for leading design quality for program teams as Quality Core Team (QCTM) for activities to include compliant application of Design controls, implementation of effective risk management activities during product/system lifecycle including product development, design V &V, design transfer, and product realization.
  • Primary focus in Risk Management through development of risk management plans, assessing complex product designs and oversight of risk management files, test, root cause analysis, risk mitigation, and other complex performance data.
  • Responsible for developing quality plans, overseeing the execution of quality plans, assessing complex product design, reviewing test and other complex performance data, analyses market feedback, lead complex root cause analysis and complex quality problem solving.
  • Ensures that appropriate quality, risk management Plans, including the implementation of Design Controls are made and include all stages of the product life cycle.
  • Supports Quality Plan design for hardware and Software design and ensure they meet quality and compliance standards for every planned milestone.
  • Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
  • Provides effective oversight of the execution of the quality, reliability, PMS Plans, any Risk Management activities, and all of design related activities during the product/system lifecycle.
  • Performs independent technical assessment on product quality performance and post-market product quality analysis to lead quality related problem solving and root cause analysis during design and manufacturing and supports field actions when required.
  • Supports stakeholders during the execution of quality system- and product audits and inspections.
  • Ability to meet short- and long-term deadlines.
  • Effectively meet the needs of internal and external customers.
  • Ability to work regularly and dependably.
  • Ability to function effectively within a dynamic team environment.
  • Demonstrate ability to cope with stress and maintain a pleasant and cooperative temperament with internal and external stakeholders.
  • Demonstrate ability to perform mental tasks such as making decisions, learning, thinking rationally and exercising good judgment.
  • Responsible for Risk Management Activities (FMEAs, hazard analysis, fault tree analysis) throughout the lifecycle of product portfolio which includes both pre-market and post-market.
  • Support post market risk assessment activities to include CAPA, IIA, HHE, and Complaint analysis as necessary.
  • Performs independent technical assessment on product quality performance and post-market product quality analysis as necessary.
  • Interactions frequently involve negotiating with customers, management, and interfacing with senior/executive level leaders regarding matters of significance to the organization.
You are a part of:

Sleep & Respiratory Care Business Group, a business group of Philips HealthTech. We are highly dynamic, ambitious, and agile within a fast-changing industry. Our vision is to work together with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.

To succeed in this role, you'll need a customer-first attitude and the following:
  • Minimum of a B.S. in a technical field, Electrical, Mechanical, Bioengineering, Software Engineering etc. Master's degree preferred.
  • Minimum of 7+ years of experience in design quality, quality engineering, and medical device risk management.
  • An experienced professional with a full understanding of ISO 14971 Risk Management Activities (FMEAs, hazard analysis, fault tree analysis).
  • Expertise validating key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
  • Electrical and software development experience is preferred.
  • Expertise with Design Quality, Reliability and Safety/Compliance is a must.
  • ASQ certifications (CQE, CRE, CMQ/OE etc) Preferred.
  • Strong understanding of medical device industry regulatory requirements including but not limited to MDSAP participating countries, ISO Standards (ISO 13485 and ISO 14971), EUMDR, IEC 62304, IEC 60601, IEC 62366.
  • Experience leading/managing critical projects.
  • Excellent organizational skills to lead and track deliverables.
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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.

How we work at Philips
Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration : There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

Why should you join Philips?

Philips is a global leader in health technology, committed to improving 2.5 billion of lives worldwide and striving to make the world healthier and more sustainable through meaningful innovation. Driven by the vision of a better tomorrow. But it's not just what we do, it's who we are. We are 75,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers' needs. It's what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.

The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

#LI-PH1

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

Client-provided location(s): San Diego, CA, USA; Pittsburgh, PA, USA; Colorado Springs, CO, USA; Bothell, WA, USA; Orange, OH, USA; Cambridge, MA, USA; Plymouth, MN, USA
Job ID: Philips-482052
Employment Type: Other

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