Head (Director)-Design Quality Engineering-Ultrasound

Job Title

Head (Director)-Design Quality Engineering-Ultrasound

Job Description

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.

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