Lead Systems Engineer, Medical Devices

Pentangle Tech Services | P5 Group; Orlando (FL); On-site; USD 120,000 - 150,000; Full time

Job summary

Philips is seeking a senior Systems Engineer to lead the design and development of clinical applications and devices, focusing on regulated medical products used in pediatric care. You will guide requirements, architecture, and NPI efforts to deliver high-quality health tech solutions.

Ideal candidates will have extensive experience in regulated environments, rigorous risk management (ISO 14971) and IEC60601-1/IEC62336 testing, plus strong cross-functional collaboration and communication skills.

Qualifications

• BS degree in engineering is required.

Responsibilities

• Overall technical leadership and responsibility for realization of a new product release and sustaining activity.
• Translation of user requirements, requirements management, top-level design, feasibility of potential solutions, decomposition of derived requirements
• Systems design/architecture and Integration oversight.
• Support for NPI efforts that create value through innovation and design, delivering high quality engineering solutions.
• Technical liaison to the program
• Defect/Risk management and Design Reviews

Skills

Engineering leadership

Regulated product development

Systems engineering

Requirements writing

Risk management ISO 14971

Safety IEC 60601-1

EMC IEC 62336 knowledge

Cross-functional collaboration

Communication skills

Education

BS degree in engineering

Master’s degree preferred

Tools

DOORS

Job description

Philips is seeking a senior Systems Engineer to lead the design and development of clinical applications and devices, focusing on regulated medical products used in pediatric care. You will guide requirements, architecture, and NPI efforts to deliver high-quality health tech solutions.

Ideal candidates will have extensive experience in regulated environments, rigorous risk management (ISO 14971) and IEC60601-1/IEC62336 testing, plus strong cross-functional collaboration and communication skills.