The Senior Manager- Design Assurance Quality Engineering will play a critical role in managing/supporting the Design Control process for new Image Guide Therapy Devices (IGTD), ensuring they are safe, reliable, and compliant with all applicable Internal/External design standards, processes, and requirements.Your role:
Functional leadership including departmental budget, mentoring, training, performance management and technical/professional development of Design Assurance team members.
Understands/implements processes and intent of all aspects of the QMS related to Design Controls.
Uses engineering principles to analyze situations or data to identify gaps between project work and QMS.
Develop mastery of Philips’ Image Guided Therapy Devices (IGTD) products and analyzes complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles.
Ensures NPI projects are adequately staffed/supported and leads/supports Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects.
Strong understanding of shelf life and biocompatibility testing (ISO 10993).
Create and facilitate updates to product risk analyses and risk management files (ISO 14971)
Develop and implement new and improved quality/compliant pre-market engineering methods, techniques, and processes.
Build rapport/stable relationships with internal teams and stakeholders.
Reporting to the Director of Quality, you will partner with R&D, Regulatory, Production/Manufacturing, quality teams and other Design Assurance team members to ensure compliance to the QMS.
This hybrid , Colorado Springs, CO based role, may require travel up to 10%.
You're the right fit if:
You have a minimum of 8 years’ experience in FDA regulated medical device environments, with a focus in Design Quality Assurance/Control, Systems Engineering and expertise applying ISO 13485, ISO 14971, 21 CR 820, EU MDR and working knowledge of ISO 10993 (Biocompatibility).
You’ve acquired a minimum of 4 years’ experience in functional team leadership, including budgetary responsibility.
You have proven analytical & problem-solving skills, a statistical background, preferred in reliability/ verification, hypothesis testing, sampling, multi-factor analyses and have used post-market analytics/statistics to report on product quality performance in the field, initiated field actions and experience with Statistical software solutions such as JMP or Minitab.
You have a minimum of a Bachelor’s Degree in a Quality, Engineering or related Scientific discipline (required), Master’s Degree desired. ASQ-CQE or similar certifications (preferred).
You have a Strong understanding of design quality tools, methods, and activities such as design traceability, Design for Reliability (DfR), Agile, SAFe, defect tracking and management tools such a Jira or Clearquest.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) .
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 (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Read more about our employee benefits (https://www.careers.philips.com/na/en/best-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 (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Philips Transparency Details:The pay range for this position is $104,000 to $178,000, 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.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-PH1It 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.Equal Employment and Opportunity Employer/Disabled/Veteran