Advanced Design Quality Assurance Engineer
In this role, you have the opportunity to
Support product development programs (new and sustaining). Lead proactive design assurance activities facilitating the development and release of high quality products. Ensure standard and process compliance. Provide guidance and support during investigation and resolution of product quality or compliance issues. Emphasis placed on knowledge of standards, regulations, investigative/root cause processes, and procedures supporting compliance to industry, PQMS, DI and CT/ AMI product quality standards and requirements. Provide technical expertise in the area of design assurance to Engineering, Operations, Customer Service, Field Service personnel and other business partners. Guiding, coaching and training respective to investigative methods, risk mitigation techniques, and general product safety.
Key Areas of Responsibility
· Integral member of product development team responsible for supporting activities required to ensure quality of the design through compliance with design controls.
· Provide guidance of Design Controls and the Product Realization Process (PRP) to the project teams.
· Support the establishment and maintenance of design and development plans in support of quality and compliance for program and project assigned.
· Work closely with product development engineering, clinical, marketing, regulatory, and other business partners to assure appropriate quality requirements are defined for the specific device application and target patient population.
· In collaboration with product development, recommend/promote testing methodologies and approaches required to confirm that the design output meets the design input for program and projects assigned.
· Participate in the review of clinical relevant test methods, design verification test plans and results, and validation test plans and results.
· Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to ensure device master record is complete and provide guidance to design engineering, manufacturing and product quality engineering for development of manufacturing test/evaluation methods and process validation.
· Works with Program Manager on Risk management activities including supporting risk management activities and essential requirements analysis.
· Ensure completion of the functional actions items /tasks and submission of deliverables to the document control system and report on functional group progress to team (including escalation and program review).
· Supports compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are achieved and ensuring DHF completeness.
· Participates in the defects classification, defect risk analysis and investigations.
· Participates in reviews related to design, validation, defect classification and documentation as required.
· Responsible for ensuring defects, design changes and document changes are processed timely and compliantly as applicable.
· Support Post Market Product Assurance, audit group, and other business partners in post-market activities.
· Work with a cross-functional, collaborative, team-based environment; work with multiple sites in various locations, time zones, and countries.
· Support program managers with identification and maintenance of program team interdependencies.
· Serve as a team member technical resource for problem investigations to guide root cause analysis and corrective action development.
· Provide regular technical and administrative input to business partners.
· Bachelor's degree in engineering/science discipline or technical certification in related field
· 2+ years of experience in product design and development or related work experience with exposure to regulated products
· Regulatory compliance awareness including design controls and risk management in a regulated industry
· Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
· Ability to learn quickly and respond to changing priorities
· Must have strong interpersonal communication skills as well as being a motivated team player
· Ability to work with global QA, RA organization
· Technical writing and presentation skills
· Good verbal and written communication skills, good team skills including project management
· Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project)
· Vocational English in writing
· Experience as a contributing member of a team to take design from concept into production
· Experience with medical device regulations
· Regulatory compliance awareness such as FDA design controls CFR 820, ISO 14971, ISO 13485, IEC60601, IEC62304 and similar
· CRE / CQE Certification
· Minitab experience- Education/Training & Experience / Background
· Statistics background
· Six Sigma / Design for Reliability / Design for Manufacturability experience
· Working knowledge of FEA simulation tools and analysis
In return, we offer you
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
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Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.
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