Senior Design Quality Engineer - Medical Device Quality Lead

Philips; Bedford (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

Philips is seeking a Senior Design Quality Engineer to lead design control processes across hardware, software, and systems, ensuring compliance with FDA regulations and ISO 13485. You will validate inputs, oversee V&V, and drive design transfer while integrating risk management and PMS insights.

The role focuses on CAPA management, post-market feedback, and continuous improvement, with collaborative leadership across cross-functional teams to deliver safe, reliable medical devices.

Qualifications

• 5+ years' experience in FDA-regulated medical device environments.
• In-depth knowledge of Risk Management (ISO 14971) and QMS Design Controls.
• Experience with Design Verification/Validation, CAPA, and defect management.
• ASQ-CQE or ISO Lead Auditor training desired.

Responsibilities

• Plan and execute comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards.
• Lead the entire design control process, from eliciting and validating design inputs to managing verification, validation, and design transfer, ensuring adherence to regulatory and quality standards.
• Draft and uphold quality engineering documents, including quality plans for hardware, software, and systems, ensuring documentation is accurate and compliant.
• Conduct assessments of product and system designs, review performance data, and perform root cause analysis to address quality deficiencies.

Job description

Philips is seeking a Senior Design Quality Engineer to lead design control processes across hardware, software, and systems, ensuring compliance with FDA regulations and ISO 13485. You will validate inputs, oversee V&V, and drive design transfer while integrating risk management and PMS insights.

The role focuses on CAPA management, post-market feedback, and continuous improvement, with collaborative leadership across cross-functional teams to deliver safe, reliable medical devices.