Head (Director)-Design Quality Engineering-Ultrasound

2 months ago

Bothell, Washington, United States Philips Full time
Job TitleHead (Director)-Design Quality Engineering-UltrasoundJob 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.

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.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

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

  • Head (Director)-Design Quality Engineering-Ultrasound

    3 weeks ago

    Bothell, Washington, United States Philips Full time

    Job TitleHead (Director)-Design Quality Engineering-UltrasoundJob DescriptionAs 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...

  • Lead Ultrasound Systems Engineer

    2 weeks ago

    Bothell, Washington, United States FUJIFILM Corporation Full time

    Position OverviewLead Ultrasound Systems EngineerFUJIFILM Corporation -- At FUJIFILM, we are committed to advancing healthcare through innovative imaging solutions. Our focus on point-of-care ultrasound technology enables healthcare professionals to deliver exceptional care across diverse environments. We pride ourselves on our values: Innovation, Curiosity,...

  • Lead Ultrasound Systems Engineer

    2 weeks ago

    Bothell, Washington, United States FFSS- FUJIFILM Sonosite Full time

    Overview Lead Ultrasound Systems Engineer - Bothell, WAFFSS - FUJIFILM Sonosite, Inc. -- At FUJIFILM Sonosite, we are committed to enhancing healthcare through innovative imaging solutions. As pioneers in point-of-care ultrasound technology, our mission is to empower clinicians worldwide to make informed decisions for their patients. Our team is driven by...

  • Engineering Director

    1 week ago

    Bothell, Washington, United States Greenpoint Technologies Full time

    Job OverviewGreenpoint Technologies is seeking a seasoned Engineering Leader to provide strategic guidance to a team of engineers from various disciplines. This role involves creating and implementing comprehensive project plans to meet customer requirements and drive business growth.Key Responsibilities:Develop and execute project plans to address research,...

  • Senior Regulatory Affairs Leader

    2 weeks ago

    Bothell, Washington, United States Philips Full time

    Job Title Senior Regulatory Affairs Leader - Ultrasound Job Description The Senior Regulatory Affairs Leader will be instrumental in formulating detailed regulatory strategies for intricate new devices and modifications in the Ultrasound sector at Philips. Your responsibilities: Oversee critical new product development initiatives, ensuring regulatory...

  • Senior RF and Analog Design Engineer

    2 days ago

    Bothell, Washington, United States Bausch Health Full time

    About the RoleWe are seeking a highly skilled Senior RF and Analog Design Engineer to join our team at Bausch Health. As a key member of our engineering team, you will be responsible for designing and developing cutting-edge medical devices that meet the highest standards of quality and safety.Key ResponsibilitiesDesign and develop RF and analog circuits for...

  • Senior Regulatory Affairs Leader

    2 weeks ago

    Bothell, Washington, United States Philips Full time

    Job Title Senior Regulatory Affairs Leader - Ultrasound Job Description The Senior Regulatory Affairs Leader will be instrumental in formulating extensive regulatory approaches for intricate new devices and modifications in the post-market phase within Philips' Ultrasound division. Your responsibilities: Oversee critical new product development initiatives,...

  • Director, Global Education Services

    4 days ago

    Bothell, Washington, United States Philips Full time

    About the RoleWe are seeking a highly experienced and skilled Director, Global Education Services to lead our comprehensive Education and Training strategy. As a key member of our team, you will be responsible for delivering innovative internal and external education and training programs, collaborating with cross-functional teams, and managing project and...

  • Packaging Design Engineer

    3 days ago

    Bothell, Washington, United States Philips Full time

    Job TitlePackaging Design EngineerJob DescriptionAbout the RoleWe are seeking a highly skilled Packaging Design Engineer to join our team at Philips. As a Packaging Design Engineer, you will be responsible for managing packaging execution projects with internal marketing, Philips Platform Team, purchasing, System Engineer/Quality and suppliers.Key...

  • Director, Global Education Services

    2 months ago

    Bothell, Washington, United States Philips Full time

    Job TitleDirector, Global Education ServicesJob DescriptionDirector, Global Education Services As our Global Education Services Director at Philips Ultrasound, you will spearhead the comprehensive Education and Training strategy while leading a diverse team of talented professionals across various countries. You will be responsible for delivering innovative...

  • Senior Acoustic Design Engineer

    3 days ago

    Bothell, Washington, United States Belcan Full time

    Job SummaryWe are seeking a highly skilled Senior Acoustic Design Engineer to join our team at Belcan. As a key member of our engineering team, you will be responsible for designing and implementing acoustic solutions to improve sound quality and reduce noise levels.Key ResponsibilitiesConduct acoustic assessments and measurements to analyze sound...

  • Civil Engineer for Aviation and Transportation

    6 days ago

    Bothell, Washington, United States Century West Engineering Full time

    Job OverviewCentury West Engineering is seeking a highly skilled Project Engineer to support our airport design projects. As a key member of our team, you will have the opportunity to work on a variety of transportation projects, utilizing your expertise in AutoCAD/Civil3D to design alignments, profiles, corridors, site grading, and surfaces.Key...

  • Director Program Management

    2 months ago

    Bothell, Washington, United States Philips Full time

    Job TitleDirector Program ManagementJob DescriptionDirector Program Management (Bothell, WA or Cambridge, MA)Philips Ultrasound is seeking a Director Program Management to lead the execution of global, cross-functional R&D/NPI Project teams responsible for launching new Point of Care Ultrasound (POCUS) solutions for Obstetrics designed to meet the needs of...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Bothell, Washington, United States Acara Solutions, An Aleron Company Full time

    Acara Solutions, An Aleron Company is seeking a highly skilled Lead Quality Assurance Engineer to become a vital part of our esteemed aerospace manufacturing client. This role offers a competitive salary range of $139K - $161K and is an entirely onsite position.The Lead Quality Assurance Engineer is a pivotal contributor who operates with a high degree of...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Bothell, Washington, United States Acara Solutions Full time

    Job OverviewJob ID#: 542085Job Category: Professional - EngineeringPosition Type: Direct PlacementDuration: Direct PlacementPosition Summary:Acara Solutions, a prominent staffing firm in the aerospace sector, is seeking a Senior Test Engineer to become a valued member of our client's organization as a salaried direct employee. The compensation range for this...

  • Systems Integration Engineer

    1 month ago

    Bothell, Washington, United States Philips Full time

    Job TitleSystems Integration EngineerJob DescriptionSystems Integration Engineer, Bothell, WAAs a Systems Integration Engineer you will help design, influence, and integrate hardware and software solutions in support of new Ultrasound product developmentYour role:As a member of the systems engineering development team, you will coordinate, influence, and...

  • Senior Quality Assurance Engineer

    1 week ago

    Bothell, Washington, United States Acara Solutions Full time

    Job OverviewJob ID#: 542085Job Category: Professional - EngineeringPosition Type: Direct PlacementDuration: Direct PlacementPosition Summary:Acara Solutions, a prominent staffing firm in the aerospace sector, is seeking a Senior Test Engineer to become a valued member of our client's team as a full-time employee. The compensation package ranges from $139K to...

  • Quality Assurance Engineer in Manufacturing

    2 weeks ago

    Bothell, Washington, United States Philips Full time

    Job TitleManufacturing Quality EngineerJob OverviewAs a Manufacturing Quality Engineer at Philips, you will be instrumental in driving excellence within the Emergency Care - Home and Public (EC-HP) division. Your primary responsibility will be to spearhead quality initiatives that align with both business objectives and customer satisfaction.The medical...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Bothell, Washington, United States Acara Solutions Full time

    Job OverviewJob ID#: 542085Job Category: Professional - EngineeringPosition Type: Direct PlacementDuration: Direct PlacementPosition Summary:Acara Solutions, a prominent staffing service in the aerospace sector, is seeking a Senior Test Engineer to become a vital part of our esteemed aerospace manufacturing client. This role offers a competitive salary range...

  • UI/UX Designer

    2 months ago

    Bothell, Washington, United States Philips Full time

    Job TitleUI/UX DesignerJob DescriptionUI/UX Designer (Bothell, WA)You will join the Ultrasound UX and workflow team, which is dedicated to creating differentiating, delightful, and impactful experiences and designs for Ultrasound. We envision, build, and deliver easy to use and impactful solutions defining the future of Ultrasound (hardware, software, and...