Project Engineer

Philips; Bothell (WA); On-site; USD 110,000 - 150,000; Full time

Job summary

Philips is seeking a Product Design Quality Engineer to ensure quality, safety, reliability, and regulatory compliance across the product lifecycle. You will partner with R&D, manufacturing, regulatory, and cross-functional teams to support development from concept to commercialization and post-market monitoring.

You will apply quality engineering principles, risk management, and continuous improvement to meet customer expectations and regulatory requirements while leading CAPA and design

Qualifications

• Degree in a technical discipline with exposure to quality systems and regulated product development.
• Experience in quality engineering, design quality, safety engineering, or related fields.
• Knowledge of quality engineering principles, design controls, risk management, and regulated environments.
• Strong analytical, problem-solving, and cross-functional collaboration skills.

Responsibilities

• Develop and execute process validation strategies to support product transfers to manufacturing with regulatory compliance.
• Lead and support Design Control activities: design input reviews, verification, validation, and design transfer.
• Create and maintain quality engineering docs: quality plans, risk files, DHF, validation reports.
• Partner with cross-functional teams to integrate quality, reliability, and PMS insights into development and lifecycle.
• Conduct design/product quality assessments and root cause investigations to resolve issues.
• Evaluate critical design attributes including usability, performance, reliability, manufacturability, safety, privacy, and security.
• Lead risk management across the product lifecycle, with monitoring and controls.
• Support audits, inspections, and CAPA processes; drive continuous improvement.

Skills

Quality engineering

Design Controls

CAPA

Regulatory compliance

Risk management

Data analysis

RCA

Verification & Validation

Documentation

Product quality

Education

Bachelor's or Master's degree in Mechanical Engineering, Electrical/Electronics Engineering, Biomedical Engineering, Life Sciences, or related technical discipline

Job description

As a Product Design Quality Engineer, you will play a critical role in ensuring the quality, safety, reliability, and regulatory compliance of innovative healthcare products throughout the product lifecycle. You will partner closely with R&D, manufacturing, regulatory, and cross-functional teams to support product development activities from concept through commercialization and post-market monitoring.

In this role, you will help drive Design Quality excellence by applying quality engineering principles, risk management methodologies, and continuous improvement practices to ensure products meet customer expectations and applicable regulatory requirements.

Your Role

• Develop and execute process validation strategies utilizing statistical methodologies to support successful product transfers into manufacturing while ensuring compliance with quality and regulatory standards.
• Lead and support Design Control activities, including design input reviews, verification, validation, and design transfer processes in accordance with established quality system requirements.
• Create, review, and maintain quality engineering documentation, including quality plans, risk management files, design history file (DHF) documentation, and validation reports.
• Partner with cross-functional teams to integrate quality, reliability, and Post-Market Surveillance (PMS) insights into product development and lifecycle management activities.
• Conduct design and product quality assessments, analyze performance data, and perform root cause investigations to identify and resolve quality issues.
• Evaluate critical design attributes including usability, performance, reliability, manufacturability, safety, privacy, and security requirements.
• Facilitate risk management activities throughout the product lifecycle, ensuring risks are identified, assessed, controlled, and monitored appropriately.
• Analyze post-market product performance and customer feedback to identify improvement opportunities and support corrective and preventive actions.
• Support internal and external audits, inspections, and compliance activities while maintaining audit-ready documentation and processes.
• Lead and execute CAPA activities, including issue investigation, root cause analysis, corrective action implementation, and effectiveness verification.
• Drive continuous improvement initiatives that enhance product quality, process effectiveness, and regulatory compliance.
• Build strong relationships across engineering, manufacturing, quality, regulatory, and supplier teams while providing quality guidance and mentorship as needed.

You're the Right Fit If you have the following required qualifications:

• Bachelor's or Master's degree in Mechanical Engineering, Electrical/Electronics Engineering, Biomedical Engineering, Life Sciences, or a related technical discipline.
• Bachelor's degree with a minimum of 2 years of experience in Quality Engineering, Design Quality, Safety Engineering, Product Development, R&D, or a related engineering discipline; or
• Master's degree with no prior professional experience required.
• Knowledge of quality engineering principles, design controls, risk management, and regulated product development environments.
• Strong analytical and problem-solving skills with the ability to evaluate data and identify trends.
• Effective communication and collaboration skills within cross-functional teams.

Preferred Qualifications

• Experience working in the medical device, healthcare technology, or other regulated industry environments.
• Six Sigma Green Belt certification or equivalent process improvement training.
• Familiarity with design verification and validation activities.
• Experience supporting CAPA, complaint investigations, and post-market quality processes.
• Knowledge of FDA, ISO 13485, IEC 62304, ISO 14971, and other applicable regulatory standards.

Preferred Skills

• Design Quality Management
• Design for Quality (DFQ)
• Data Analysis and Interpretation
• Root Cause Analysis (RCA)
• Corrective and Preventive Action (CAPA)
• Risk Management and Risk Assessment
• Regulatory Compliance
• Product Quality and Reliability
• Design Verification and Validation
• Privacy, Safety, and Security
• Technical Documentation
• Product Testing and Validation Strategies

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.