Philips Senior Manager-Design Assurance Quality Engineering 

United States, Minnesota 

383087582

Senior Manager-Design Assurance Quality Engineering

Your role:

• Responsible for functional/operational team leadership including budgeting, training, performance management, technical/professional development and mentorship to engineers and quality teams, helping them meet schedules, resolve technical challenges, and manage performance requirements, while fostering a culture of continuous improvement and quality excellence.
• Will ensure that NPI projects are adequately staffed/supported and lead/support CAPA and QMS continuous improvement projects. Responsible for implementing processes and intent of all aspects of the QMS related to Design Controls.
• Leads the creation/review of risk management files-plans, product hazard analysis, FMEAs, Risk Management Matrix, Benefit Risk Determination and Ensures Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc.
• Work with teams and other Design Assurance team members to ensure compliance to the QMS and utilize engineering principles, analyze situations/data to identify gaps between project work and QMS.
• Will develop mastery of Philips IGTD products and analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles

You're the right fit if:

• You have a minimum of 8+ years’ experience in FDA regulated medical device environments, with a focus on Design Assurance/Control,detailed knowledge of Risk Management (ISO 14971) and strong Understanding of all aspects of the QMS related to Design Controls.
• You’ve acquired a minimum of 3+ years’ experience in functional team leadership, including departmental budget, mentoring, training, performance management and technical/professional development of Design Assurance team members.
• You have a strong statistical background preferred in reliability / verification, hypothesis testing, sampling, multi-factor analysis, with strong understanding of shelf life and biocompatibility testing.
• You have extensive experience supporting the creation and review of all medical device documentation including- Safety Classification, Design Verification test/regression plans, associated test protocols/reports, issue tracking/resolution and auditing Design History Files (DHF).
• You have the proven ability to cultivate and maintain strong relationships with internal and external stakeholders, at all levels, by sharing knowledge, providing insights, and ensuring alignment with software quality standards, regulatory requirements, and project objectives.
• You have a minimum of a Bachelor’s Degree in Quality, Engineering or a related Scientific discipline (required). ASQ certifications (desired).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

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.

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Philips Transparency Details:

• The pay range for this position in Plymouth, MN is $120,488 to $192,780.

Additional Information

• This role may require travel up to 10%.
• 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
  Plymouth, MN.