Philips

Job Title

System Test Designer (System V&V) - Medical Devices

Job Description

In late January, we announced that Bridgefield Capital signed an agreement to acquire Philips’ Emergency Care business which includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions. We expect the transaction to close at the end of 2025.

With Bridgefield’s support and building on our 40+ year legacy of growth and innovation in emergency medical technology, the Emergency Care business will continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments.”

Philips Emergency Care is seeking a dynamic and experienced Software Test Manager to lead our talented team of test engineers in delivering cutting-edge Informatics solutions. You will play a crucial role in ensuring the quality and reliability of our life-saving technologies within an Agile environment, driving innovation and fostering a high-performing team.

In this role, you have the opportunity to

Be an integral part of the Emergency Care and Resuscitation (ECR) R&D leadership team, actively participating in cardiac defibrillator product development. ECR team has a broad product portfolio of advanced life support solutions, automated external defibrillators, and data management solutions. Our mission is to design, produce, and deliver every solution as if the life of someone we love depends on it. Every day, we empower and enable our customers – from clinicians to paramedics, first responders to the everyman – to save lives using our innovative, market-leading technology.

We are looking for a passionate System Test Designer to join us as we strengthen our product portfolio, expand our services and solutions, and bring game-changing technology to market. This team member will be responsible for working collaboratively with a team of cross-functional engineers.

You are responsible for

• Supporting product verification through the phases of the Medical Device lifecycle.
• Providing technical support and leadership on a cross-functional team
• Define, document, and continuously improve verification tests including conducting peer reviews and maintaining traceability to requirements
• Perform verification tests and conduct analysis of the test results to ensure complete verification of the requirements
• Identifying, analyzing and driving technical issues to resolution
• Perform work with little to no supervision as department subject-matter expert
• Participates in design reviews, including reviews of design verification plans, reports, and test artifacts.
• Development and execution of validation test plans , test records and Test fixtures
• Keeps abreast of new developments in all relevant technological domains.
• Provides technical leadership to ensure overall product development success.
• Keeps abreast of new developments in all relevant technological domains.
• Contributes to technology roadmaps and other strategic related activities
• Provides technical leadership to ensure overall product development success.

To succeed in this role, you should have the following skills and experience

• Bachelor’s degree in Electronics/Computer Science/Electrical Engineering or related field, good to have a Master’s degree.
• Total 5+ years’ experience with Minimum 3 years of experience in medical device or other similar industry
• Demonstrated knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC 60601-1-1 (CE mark), ISO 13485, and risk management requirements and development dependencies.
• Solid understanding of medical device product development, preferably Design Control experience with Class-III/Class-3 medical devices (FDA CFR Title 21, 820.30)
• Experience specific to product verification.
• Solid understanding of System Verification and Validation test plan/protocols, executing V&V activities, generating, and analyzing test reports
• Experience in designing and assessing compliance to national/international standards.
• Strong technical writing/documentation skills for a regulated medical device design environment, including requirements definition
• Proven ability to communicate in both verbal and written form to technical and non-technical customers, stakeholders, and various levels of management.
• Possess strategic agility/vision: Sees ahead clearly; can anticipate future concerns.
• Develops and maintains effective relationships and is capable of quickly earning trust and respect.
• Ability to study and understanding of Schematics and PCBA
• Board bring up experience.
• Good Knowledge of EMI/EMC (IEC- 60601-1-2)artifacts and testing , ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle).
• Strong knowledge of embedded systems, real-time operating systems (RTOS), and microcontroller-based architectures.
• Proficient in test development tools, scripting languages (Python, Shell, etc.), and test automation frameworks.
• Experience with communication protocols (I2C, SPI, UART, CAN, BLE, etc.).
• Experience with hardware-in-the-loop (HIL) and system simulation environments.
• Experience with version control systems (Git) and requirements management tools.

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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