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Philips

Makes medical devices and personal health products

Advanced Design Quality Engineer

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeSuzhou, Jiangsu, ChinaNo salary listedIn-person

About the Job

Requirements

  • A Bachelor's degree in Mechanical Engineering, Electronics Engineering, or Science, or equivalent vocational education is required.
  • No prior experience is required for candidates with a Bachelor's degree, or at least 4 years of experience in Quality Engineering, Safety Engineering, R&D Engineering, or equivalent is required for candidates with vocational education.
  • Six Sigma Green Belt certification is preferred.
  • Knowledge of Design Quality Management, Data Analysis and Interpretation, Design for Quality, Root Cause Analysis, 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, and Product Test Design is preferred.

Responsibilities

  • Guide implementation of comprehensive process validation plans using statistical tools to ensure effective transition of new products to production, working under general supervision.
  • Ensure smooth execution of the design control process, from eliciting and validating design inputs to managing verification, validation, and design transfer, ensuring compliance with regulatory and quality standards.
  • Review and assess detailed quality engineering documents, including quality plans for hardware, software, and system design, ensuring accuracy and regulatory compliance.
  • Propose and initiate quality improvement projects, integrating quality, reliability, and Post Market Surveillance plans at all stages of the product lifecycle.
  • Review and evaluate product and system designs, guide performance data analysis, and perform root cause analysis to address quality deficiencies.
  • Ensure validation of essential design inputs such as usability, reliability, performance, manufacturability, and safety, aligning with quality standards and regulatory requirements.
  • Share subject matter expertise and suggest proactive methods to strengthen risk management efforts, ensuring risks are identified, assessed, and mitigated throughout the product lifecycle.
  • Address and resolve quality engineering issues of medium to high complexity, applying established processes and policies.
  • Suggest efficient use of post-market analytics to assess field performance, provide feedback to manufacturing and design teams, and implement field actions as necessary.
  • Prepare for and support quality audits and inspections, ensuring necessary documentation and processes are in place and compliant with internal and external standards.
  • Apply continuous improvement techniques to enhance quality practices and maintain readiness for quality audits, ensuring adherence to internal and external standards.

Desired Qualifications

  • Six Sigma Green Belt certification.
  • Design Quality Management, Data Analysis and Interpretation, Design for Quality, Root Cause Analysis, 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, and Product Test Design.

About the Company

Philips

Makes medical devices and personal health products

Philips makes medical equipment and software for hospitals and care providers, along with personal health products for consumers. Its hospital portfolio spans MRI and CT scanners, ultrasound, image-guided treatment systems and patient monitors, while Sonicare and Avent cover oral health and baby care. Clinical software connects medical images and patient data across care teams, and the company earns revenue from equipment, software, maintenance and consumer product sales. It works with health systems through long-term technology and service partnerships, including solutions for care at home. Founded in 1891, Philips is headquartered in Amsterdam, the Netherlands.

Company size
10,001+
Company stage
Acquired
Total funding
$164.7M
Headquarters
Andover, MN
Founded
1891

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