Systems Test Engineer

The Systems Test Engineer will be responsible for creating and executing comprehensive verification and validation plans for medical devices, including critical sub-assemblies and system-level formal verification. This role involves designing test protocols, developing test methods, meticulously reporting test results, and managing defects within the tracking system. The engineer will collaborate with design teams to isolate design errata, perform failure analysis, and verify design fixes, ensuring all activities comply with stringent Quality System requirements, including FDA and EUMDR regulations. Supporting test estimation and planning is also a key aspect of this position.

Must Have

• Create Verification and Validation plan.
• Testing and debug of critical sub-assemblies.
• Perform system-level formal verification prior to production release.
• Perform V&V activities for FDA and EUMDR remediation projects.
• Design test protocols and develop test methods.
• Report and document test results, entering defects into the defect tracking system.
• Work with design teams to isolate design errata, perform failure analysis, and verify design fixes.
• Ensure all verification activities are conducted in accordance with Quality System requirements.
• Minimum 6 to 9 years of experience on system verification and validation of medical devices.
• Hands-on experience of test method validation.
• Hands-on experience of remediation projects for FDA or EUMDR.
• Understand and Comply with Philips QMS.
• Process oriented with basic knowledge of FDA and/or ISO/IEC regulations.
• Technical documentation authoring and editing skills.
• Proficiency with MS Office MS excel or equivalent.
• Good written and verbal communication skills in English.

Good to Have

• Experience on V&V of ventilator.
• Ability to implement process automation/innovation.
• Ability to learn new PLM/ALM tools and become productive.
• Ability to work across functional groups.
• Familiarity with quality procedures and documentation.

Job Title

Systems Test Engineer

Job Description

Job title:

Systems Test Engineer

Your role:

• Create Verification and Validation plan.
• Testing and debug of critical sub-assemblies.
• Conduct early dry run testing of system verification test procedures to ensure their high accuracy as well as provide timely information on product performance to the project team.
• Perform system-level formal verification prior to production release to identify problems.
• Perform V&V activities for FDA and EUMDR remediation projects.
• Design test protocols and develop test methods
• Reporting and documenting the test results in test reports and where appropriate, entering defects into the defect tracking system.
• Enables and/or performs functional testing through the development of robust and reusable tests.
• Work with design teams to isolate design errata, perform failure analysis, and verify design fixes.
• Support and work collaboratively with external teams to verify system performance.
• Supporting the test estimation and planning activities.
• Ensuring that all verification activities are conducted in accordance with Quality System requirements.
• Following improvements in the profession of test engineering.
• Mentor team members.
• Ability to implement process automation/innovation.
• Ability to learn new PLM/ALM tools and become productive.

You're the right fit if:

• Bachelor’s or Master’s degree in Mechanical / Electronics / Electrical / Biomedical Engineering with a broad technical understanding and interest.
• Minimum 6 to 9 years of experience on system verification and validation of medical devices.
• Experience on V&V of ventilator will be preferred.
• Hands on experience of test method validation.
• Hands on experience of remediation projects for FDA or EUMDR.
• Understand and Comply with Philips QMS.
• You are process oriented with basic knowledge of FDA and/or ISO/IEC regulations.
• Technical documentation authoring and editing skills.
• Good written and verbal communication skills.
• Ability to work across functional groups.
• Familiarity with quality procedures and documentation.
• Proficiency with MS Office MS excel or equivalent.
• Good communication of both written and spoken English.

How we work together

We believe that we are better together than apart. This is an office-based role, which means working in-person at least 3 days per week.

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. Do the work of your life to help the lives of others.

• Learn more about our business.

• Discover our rich and exciting history.

• 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 commitment to diversity and inclusion here.

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About Us

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.

For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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