Systems Test Engineer - Medical Device (San Diego, CA)
Philips
Summary
As a System Test Engineer on the multidisciplinary IntraSight Team, you will support innovative 2D and 3D imaging solutions by leading system-level verification and validation across NPI and sustaining projects. You will execute test plans, resolve technical issues, and collaborate with internal teams and suppliers to deliver safe, reliable, and compliant medical devices.
Job description
Your role:
- Plan and execute system-level verification and validation for the IntraSight platform across NPI and sustaining engineering projects, from concept through release and post-market support.
- Develop test plans, protocols, and reports, and perform functional, integration, regression, reliability, and compliance testing internally and with external test laboratories.
- Collaborate with engineering, quality, regulatory, manufacturing, suppliers, and test partners to ensure robust test coverage, resolve issues, and support root cause and failure investigations.
- Maintain traceability and audit-ready documentation, ensure compliance with medical device standards and regulations, and improve test methods, automation, and infrastructure.
You're the right fit if:
- Bachelor's or Master's degree in Electrical, Mechanical, Biomedical, Systems Engineering, or a related field, with 5+ years of system verification and validation experience in medical devices or another regulated industry.
- Hands-on experience testing complex products across NPI, sustaining engineering, and design changes, including system integration, regression, reliability, risk management, traceability, and audit-ready documentation.
- Working knowledge of IEC 60601-1 and IEC 60601-1-2; familiarity with IEC 60601-2-34 and IEC 60601-2-37, external compliance testing, complaint investigations, CAPA, and post-market activities is a plus.
- Strong analytical, troubleshooting, communication, and root cause analysis skills, with experience collaborating across global, cross-functional teams, suppliers, and contract manufacturers; familiarity with requirements and test management tools is preferred (DNG, Windchill, test automation frameworks).
- You must be able to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
Requirements
- Bachelor's or Master's degree in Electrical, Mechanical, Biomedical, Systems Engineering, or a related field
- 5+ years of system verification and validation experience in medical devices or another regulated industry
- Hands-on experience testing complex products across NPI, sustaining engineering, and design changes
- Experience with system integration, regression, reliability, risk management, traceability, and audit-ready documentation
- Working knowledge of IEC 60601-1 and IEC 60601-1-2
- Strong analytical, troubleshooting, communication, and root cause analysis skills
- Experience collaborating across global, cross-functional teams, suppliers, and contract manufacturers
- Familiarity with requirements and test management tools (DNG, Windchill, test automation frameworks) preferred
- Familiarity with IEC 60601-2-34 and IEC 60601-2-37, external compliance testing, complaint investigations, CAPA, and post-market activities is a plus
- US work authorization required; no visa sponsorship
Benefits
- Paid Time Off
- 401(k) Match
- Health Savings Account With Company Contribution
- Employee Stock Purchase Plan
- Education Reimbursement
- Annual Incentive Bonus
- Sales Commission
- Long-Term Incentives
Company overview
Koninklijke Philips N.V., commonly known as Philips, is a Dutch multinational health technology company that has evolved from its origins as a consumer electronics conglomerate into a leading global healthcare solutions provider. Founded in 1891 in Eindhoven, Netherlands, Philips has transformed its business focus since the 2010s to concentrate exclusively on health technology. The company operates through three main divisions: Diagnosis and Treatment, which manufactures advanced medical imaging equipment including MRI, CT, and ultrasound scanners; Connected Care, specializing in patient monitoring systems and respiratory care products under the Respironics brand; and Personal Health, producing consumer healthcare products like electric shavers, Sonicare toothbrushes, and Avent childcare items. With 68,419 employees worldwide and annual revenues of €18.02 billion (2024), Philips maintains its global headquarters in Amsterdam while operating manufacturing, R&D, and sales facilities across 26 countries. The company has strategically divested its consumer electronics, lighting, and home appliance businesses to become a pure-play health technology organization, positioning itself at the forefront of medical innovation and digital healthcare solutions.