Advanced Design Quality Assurance Engineer

This role supports product development programs, leading proactive design assurance activities to ensure high-quality product releases. The engineer will ensure compliance with standards and processes, provide guidance on product quality and compliance issues, and offer technical expertise in design assurance to engineering and business partners. Key responsibilities include guiding design controls, participating in test plan reviews, managing risk, and supporting CAPA investigations.

Must Have

• 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.
• Provide technical expertise in the area of design assurance to Engineering to business partners.
• 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 to the project teams.
• Work closely with product development engineering, clinical, marketing, regulatory, and other business partners to assure product requirement definition and designated patient population.
• Participate in the review of clinical relevant test methods, design verification test plans and results, and validation test plans and results.
• Work with Program Manager on Risk management activities including supporting risk management activities and essential requirements analysis.
• Support compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are achieved and ensuring DHF completeness.
• Participate in reviews related to design, validation, defect classification and investigation and design changes.
• Support Post Market Product Assurance, audit group, and other business partners in post-market activities.
• Serve as a team member technical resource for CAPA investigations to guide root cause analysis and corrective action development.
• Bachelor's degree in engineering/science discipline or technical certification in related field.
• 4+ years of experience in quality product design and development or related work experience with exposure to regulated products.
• Experience in regulatory compliance including design controls and risk management in a regulated industry.
• Experience working with ISO 13485, CFR 820 standards.
• Strong interpersonal communication skills.
• Motivated team player.
• Fluent in English.

Good to Have

• Experience working on a global environment.
• 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, ISO 14971, IEC60601, IEC62304 and similar.
• Statistics background.

You will 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 and 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. Provide technical expertise in the area of design assurance to Engineering to business partners.

Your role:

• 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 to the project teams.
• Work closely with product development engineering, clinical, marketing, regulatory, and other business partners to assure product requirement definition and designated patient population.
• Participate in the review of clinical relevant test methods, design verification test plans and results, and validation test plans and results.
• Work with Program Manager on Risk management activities including supporting risk management activities and essential requirements analysis.
• Support compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are achieved and ensuring DHF completeness.
• Participate in reviews related to design, validation, defect classification and investigation and design changes.
• Support Post Market Product Assurance, audit group, and other business partners in post-market activities.
• Serve as a team member technical resource for CAPA investigations to guide root cause analysis and corrective action development.

You're the right fit if you have:

• Bachelor's degree in engineering/science discipline or technical certification in related field
• 4+ years of experience in quality product design and development or related work experience with exposure to regulated products
• Experience in regulatory compliance including design controls and risk management in a regulated industry
• Experience working with ISO 13485, CFR 820 standards
• Must have strong interpersonal communication skills as well as being a motivated team player
• Fluent in English

Preferred Qualifications

• Experience working on a global environment
• 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, ISO 14971, IEC60601, IEC62304 and similar
• Statistics background

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

Onsite roles require full-time presence in the company’s facilities.

Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

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 the lives of others.

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• Discover our rich and exciting history

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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

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