Systems Design Quality Engineer

Job Title

Systems Design Quality Engineer

Job Description

Job Title: Systems Design Quality Engineer

Job Responsibilities:
• Guides the implementation of comprehensive process validation plans using statistical tools to ensure effective transition of new products to production, working under general supervision.
• Ensures the smooth execution of the design control process, from eliciting and validating design inputs to managing verification, validation, and design transfer, ensuring full compliance with regulatory and quality standards.
• Reviews and assesses the detailed quality engineering documents, including quality plans for hardware, software, and system design, ensuring accuracy and regulatory compliance.
• Proposes and initiates multiple quality improvement projects, integrating quality, reliability, and Post Market Surveillance (PMS) plans at all stages of the product lifecycle.
• Reviews and constantly evaluates product and system designs, guides the analysis of performance data, and performs root cause analysis to address quality deficiencies and ensure design excellence.
• Ensures validation of essential design inputs such as usability, reliability, performance, manufacturability, and safety, aligning with quality standards and regulatory requirements.
• Shares subject matter expertise and suggests proactive methods to strengthen risk management efforts, ensuring that risks are identified, assessed, and mitigated throughout the product lifecycle.
• Addresses and resolves quality engineering issues of medium to high complexity, applying established processes and policies to provide efficient resolutions.
• Suggests efficient utilization of post-market analytics to assess field performance, provide feedback to manufacturing and design teams, and implement field actions as necessary.
• Prepares for and support quality audits and inspections, ensuring all necessary documentation and processes are in place and compliant with internal and external standards.
• Applies continuous improvement techniques to enhance quality practices and maintain readiness for quality audits, ensuring adherence to both internal and external standards.

Minimum required Education:
Bachelor's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent

Minimum required Experience:

• 5-7 years of experience in Quality Engineering, Safety Engineering, R&D Engineering

• Experience working with both hardware & software products preferred

Preferred Experience:
5-8 years of experience in medical device R&D, quality, or safety

Preferred Certification:
Six Sigma Green Belt

Preferred Skills:

• Electrical/Hardware/Software

• Experience in IEC 62304/82304 standards mandatory

• Design Quality 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
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
Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and 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.