Systems Design Quality Engineer (E2W)

The Systems Design Quality Engineer (E2W) at Philips assesses medical device suppliers, products, and regulatory compliance. This role involves creating and executing process validation strategies, managing the design control process from input validation to design transfer, and drafting quality engineering documents. The engineer ensures quality improvement, conducts design assessments, validates critical design inputs, and guides risk management. They also leverage post-market data, prepare for audits, manage CAPA processes, and apply continuous improvement techniques to enhance product quality and reliability.

Must Have

• Assess medical device suppliers, products, verification, product safety risk, regulatory compliance.
• Create and execute comprehensive process validation strategies using statistical tools.
• Handle the entire design control process, from eliciting and validating design inputs to managing verification, validation, and design transfer.
• Draft and update detailed quality engineering documents, including quality plans for hardware, software, and systems.
• Ensure success of quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights.
• Conduct thorough assessments of product and system designs, review performance data, and perform root cause analysis.
• Validate critical design inputs such as usability, reliability, performance, manufacturability, and safety.
• Guide comprehensive risk management activities throughout the product lifecycle.
• Leverage post-market performance data to assess product effectiveness in the field.
• Ensure preparation for quality audits and inspections.
• Record, manage, and execute CAPA processes.
• Apply continuous improvement techniques to enhance quality practices.
• Build effective relationships with internal and external stakeholders.
• Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
• Minimum 5 years of experience in product Quality Design Engineering, Product Design Safety Engineering, R&D Engineering or equivalent.
• Minimum 2 years experience of working with Global product Medical Device Regulations.

Good to Have

• Electrical / Mechanical Engineering degree.
• Medical Device supplier audit experience / certification (e.g. ISO13485).
• Six Sigma Green Belt certification.
• Design Quality Medical Device Management
• Data Analysis & Interpretation
• Design for Quality (DFQ)
• Root Cause Analysis (RCA)
• CAPA Methodologies
• Regulatory Requirements
• Privacy, Safety and Security Risk Assessment
• Technical Documentation
• Continuous Improvement
• Product Quality and Reliability
• Defect Management
• Design Verification Planning
• Design Validation Planning
• Product Test Design

Your Role & Responsibilities:

• Assesses medical device suppliers, products, verification, product safety risk, regulatory compliance for suitability and effectiveness for global markets
• Creates and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
• Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
• Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
• Ensures success of quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability.
• Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.
• Leverages post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams, and initiating corrective actions when necessary.
• Ensures preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards.
• Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement.
• Applies continuous improvement techniques to enhance quality practices, ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle.
• Builds effective relationships with internal and external stakeholders, providing guidance and mentorship to ensure alignment with quality standards and project milestones.

You're the right fit if:

Minimum required Education:

Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.

Minimum required Experience:

• Minimum 5 years of experience with Bachelor's in areas such as product Quality Design Engineering, Product Design Safety Engineering, R&D Engineering or equivalent
• Minimum 2 years Experience of working with Global product Medical Device Regulations

Preferred Education: Electrical / Mechanical Engineering

Preferred Experience: Medical Device supplier audit experience / certification (e.g. ISO13485)

Preferred Certification: Six Sigma Green Belt

Preferred Skills:

• Design Quality Medical Device Management
• Data Analysis & Interpretation
• Design for Quality (DFQ)
• Root Cause Analysis (RCA)
• CAPA Methodologies
• Regulatory Requirements
• Privacy, Safety and Security Risk Assessment
• Technical Documentation
• Continuous Improvement
• Product Quality and Reliability
• Defect Management
• Design Verification Planning
• Design Validation Planning
• Product Test Design

How we work together

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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.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

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 culture of impact with care here.