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As a key member of the Philips Ultrasound Quality Organization, the Head of Design Quality Engineering will lead and develop a global team of Design Quality Engineers to support the development and introduction of new Ultrasound products and sustaining releases. As one of the key growth engines for Philips, Ultrasound is targeting to transform our innovation engine to accelerate how quickly we can develop new products/features and enhancements that meet the needs of our patients and customers.

Your role:

• Responsible for the strategic and functional leadership of the Design Quality organization to support the development and introduction of new products and sustaining releases first time right. This includes design related and risk activities during the product/system lifecycle design, V &V activities, design transfer, and product realization

• Responsible for developing and leading a high performing global Design Quality team.

• Responsible for ensuring Ultrasound products / offerings are developed in accordance with Philips’ design control requirements, all applicable standards/regulations and state-of-the-art product standards

• Responsible for driving a culture of quality and first time right to ensure all products meet safety, reliability and efficacy requirements

• Reporting to the Quality Leader-Ultrasound, you will partner with R&D, Product Management, Medical Safety & Clinical and other key functions to ensure the safety, reliability and efficacy of Philips’ Ultrasound products by supporting NPIs and sustaining releases.

• This Hybrid based role may require travel up to 20% .

• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to our Ultrasound sites in Bothell, WA, Cambridge, MA or Reedsville, PA.

You're the right fit if:

• You’ve acquired a minimum of 10 years’ experience working in FDA regulated medical device quality, with a focus in Design Quality Engineering in support of the development and introduction of new products and sustaining releases.

• You have a minimum of 5 years’ experience in Functional and Strategic leadership of Design Quality Engineering teams.

• You have excellent written/verbal communication skills, with the ability to effectively engage with key stakeholders at all levels of the organization (e.g. R&D, Product Management, Medical Safety etc.).

• You have previous experience engaging with FDA investigators, other external regulators and auditors during inspections/audits and have the ability to effectively defend the approach/logic/process).

• Have a deep understanding of regulatory requirements including 21 CFR 820, ISO 13485, and ISO 14971.

• You have proven expertise in translating complex designs/principles/technical documents into audit/regulatory ready design documents/records.

• Have experience in statistical techniques, including design of experiments (DOE) and sampling plans to analyze results effectively.

• You have a minimum of a Bachelor’s Degree (Required) in Engineering, Quality, Regulatory or comparable disciplines.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

• Read more about our employee benefits.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Philips Transparency Details

The pay range for this position is $137,000 to $236,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

#LI-PH1

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.

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