Director-Design Quality Engineering-Ultrasound

Director Of Design Quality EngineeringAs a key member of the Philips Ultrasound Quality Organization, the Director of Design Quality Engineering will lead/develop a global Design Quality Engineering team to support the development and introduction of new Ultrasound products and sustaining releases. Your role includes:Responsible for the strategic/functional leadership and development of the Ultrasound Design Quality organization, supporting the development and introduction of new products/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 realizationResponsible for ensuring Ultrasound products/offerings are developed in accordance with Philips' design control requirements, all applicable standards/regulations and state-of-the-art product standardsResponsible for driving a culture of quality and first time right to ensure all products meet safety, reliability and efficacy requirementsReporting 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.You're the right fit if:You have a minimum of 10+ years' experience in Design Quality Engineering /Risk management for FDA regulated Medical Device (21 CFR 820, ISO 13485/14971) New Product Introduction/Sustaining environments, with a minimum of 5+ years' experience in Functional/ Strategic leadership of Design Quality Engineering teams.You have extensive experience engaging with FDA investigators, other external regulators/auditors during inspections/audits and able to effectively defend the approach/logic/process.You have proven expertise in translating complex designs/principles/technical documents into audit/regulatory ready design documents/records and highly skilled 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.This is an Office-based role.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.Philips Transparency Details:The pay range for this position in Bothell, WA, San Diego, CA and Cambridge, MA is $172,200 to $275,520. The pay range for this position in Plymouth, MN is $161,438 to $258,300. The pay range for this position in Nashville, TN and Reedsville, PA is $153,750 to $246,000. 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. The actual base pay offered may vary within the posted ranges 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.Additional Information: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. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA, San Diego, CA, Reedsville, PA, Plymouth, MN, Nashville, TN or Cambridge, MA. May travel up to 15%.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.