System Engineer

Philips; Bothell (WA); On-site; USD 90,000 - 140,000; Full time

Job summary

Philips is seeking a Systems Design Quality Engineer to drive design quality across product lifecycles in a healthcare context. You will lead validation, design control, and CAPA programs, collaborate with R&D, manufacturing, and regulatory teams, and ensure rigorous documentation and risk management practices.

The role emphasizes usability, reliability, privacy, and security considerations, with a focus on patient safety and regulatory compliance across design transfers and post-market

Qualifications

• Minimum required Education: Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
• Minimum required Experience: Minimum 2 years of experience with a Bachelor's degree in areas such as Quality Engineering, Safety Engineering, R&D Engineering, or equivalent OR no prior experience required with a Master's Degree.
• Preferred Certification: Six Sigma Green Belt

Responsibilities

• Develop and execute process validation strategies using statistical methodologies to ensure successful transfers of new products into manufacturing while meeting quality, regulatory, and business requirements.
• Lead and support Design Control activities, including design inputs, design reviews, verification, validation, and design transfer, ensuring compliance with applicable quality system and regulatory standards.
• Create, review, and maintain quality engineering documentation, including quality plans, risk management files, validation protocols and reports, and DHF documentation.
• Drive continuous product quality improvements by integrating quality, reliability, and PMS insights throughout the product lifecycle.
• Assess product and system designs, analyzing performance data, and conducting root cause investigations to identify, address, and prevent quality issues.
• Evaluate critical design requirements related to usability, reliability, performance, manufacturability, safety, privacy, and security to ensure products meet customer and regulatory expectations.
• Facilitate risk management activities across the product lifecycle, ensuring risks are effectively identified, assessed, controlled, and monitored to support patient safety and product quality.
• Leverage post-market performance data and customer feedback to identify opportunities for improvement and support corrective and preventive actions.
• Support internal and external audits, inspections, and compliance activities by maintaining audit-ready documentation and ensuring adherence to quality standards.
• Lead CAPA activities, including issue identification, root cause analysis, corrective action implementation, and effectiveness verification to drive sustainable improvements.
• Apply continuous improvement methodologies to enhance quality processes, strengthen compliance, and improve operational effectiveness.
• Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality to ensure successful project execution and high-quality product outcomes.
• Build strong relationships with internal and external stakeholders while providing quality guidance and mentorship to support project milestones and organizational objectives.

Skills

Design Quality Management

Data Analysis & Interpretation

Design for Quality

Root Cause Analysis

CAPA Methodologies

Regulatory Requirements

Privacy, Safety, and Security

Technical Documentation

Product Quality and Reliability

Design Validation Planning

Product Test Design

Education

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

Job description

Philips is hiring Systems Design Quality Engineer

In this role, you have the opportunity to make a real impact by

• Developing and executing process validation strategies using statistical methodologies to ensure successful transfers of new products into manufacturing while meeting quality, regulatory, and business requirements.
• Leading and supporting Design Control activities, including design inputs, design reviews, verification, validation, and design transfer, ensuring compliance with applicable quality system and regulatory standards.
• Creating, reviewing, and maintaining quality engineering documentation, including quality plans, risk management files, validation protocols and reports, and Design History File (DHF) documentation.
• Driving continuous product quality improvements by integrating quality, reliability, and Post-Market Surveillance (PMS) insights throughout the product lifecycle.
• Assessing product and system designs, analyzing performance data, and conducting root cause investigations to identify, address, and prevent quality issues.
• Evaluating critical design requirements related to usability, reliability, performance, manufacturability, safety, privacy, and security to ensure products meet customer and regulatory expectations.
• Facilitating risk management activities across the product lifecycle, ensuring risks are effectively identified, assessed, controlled, and monitored to support patient safety and product quality.
• Leveraging post-market performance data and customer feedback to identify opportunities for improvement and support corrective and preventive actions.
• Supporting internal and external audits, inspections, and compliance activities by maintaining audit‑ready documentation and ensuring adherence to quality standards.
• Leading CAPA activities, including issue identification, root cause analysis, corrective action implementation, and effectiveness verification to drive sustainable improvements.
• Applying continuous improvement methodologies to enhance quality processes, strengthen compliance, and improve operational effectiveness.
• Collaborating with cross‑functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality to ensure successful project execution and high‑quality product outcomes.
• Building strong relationships with internal and external stakeholders while providing quality guidance and mentorship to support project milestones and organizational objectives.

You're the right fit if you have the following requirements:

• Minimum required Education: Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
• Minimum required Experience: Minimum 2 years of experience with a Bachelor's degree in areas such as Quality Engineering, Safety Engineering, R&D Engineering, or equivalent OR no prior experience required with a Master's Degree.

Preferred Certification: Six Sigma Green Belt

Preferred Skills:

• Design Quality Management
• Data Analysis & Interpretation
• Design for Quality (DFQ)
• Root Cause Analysis (RCA)
• CAPA Methodologies
• Regulatory Requirements
• Privacy, Safety, and Security
• Technical Documentation
• Product Quality and Reliability
• Design Validation Planning
• Product Test Design

What you’ll gain:

When you choose to work at Philips you’ll work on life‑changing projects; and contribute to innovative health technologies and solutions that improve lives around the world. It could be life‑changing for you too, with the opportunity to embrace new experiences, learn new skills and make new connections.

For this project, you’ll work for Philips and become a contract or permanent employee of a Randstad company. As a contractor at Philips, you'll enjoy cutting‑edge challenges and unexpected experiences that make you a more in‑demand professional. And as an employee of a Randstad company, you can expect to receive a range of benefits including ongoing support with your personal development and future prospects.

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. As a contractor or freelancer at Philips, you’ll be part of our diverse collaborative team, helping the lives of others through the contribution you make each day.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by a Randstad company and will not be an employee of Philips.