Senior Systems Engineer – Medical Devices, Cross-Functional Leader

Philips

San Diego (CA)

On-site

USD 115,000 - 182,000

Full time

3 days ago
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Job summary

Philips is seeking a Senior Systems Engineer in San Diego, CA to provide technical leadership for capital equipment development and translate clinical, customer, and regulatory needs into robust system solutions.

You will lead cross-functional design activities, ensure end-to-end traceability, and guide verification, validation, and risk management across multiple disciplines. Onsite work is required.

Qualifications

  • Must have 5+ years in systems engineering, product development, or technical project leadership in medical devices or regulated industries.
  • Experience with system architecture, requirements, interface definition, verification planning, and requirements traceability.
  • Knowledge of medical device design controls, risk management, and verification/validation, including ISO 14971 and IEC 60601.

Responsibilities

  • Lead system design and architecture for projects, defining requirements, interfaces, and design decisions.
  • Translate clinical workflows and regulatory needs into clear system requirements with end-to-end traceability.
  • Maintain Design History Files (DHF) and Design and Development Files (DDF) per design controls and regulatory standards.
  • Drive risk management, verification and validation planning, design reviews, and change-control activities with cross-functional teams.
  • Manage project scope, schedules, resources, risks, and communicate progress to stakeholders.

Skills

System engineering
Requirements development
Interface definition
Design controls
Cross-functional leadership

Education

Bachelor's or Master's in Systems/ Biomedical/ Electrical/ Mechanical/ Software Engineering

Tools

DOORS
DNG
Windchill
Jira

Job description

Philips is seeking a Senior Systems Engineer in San Diego, CA to provide technical leadership for capital equipment development and translate clinical, customer, and regulatory needs into robust system solutions.

You will lead cross-functional design activities, ensure end-to-end traceability, and guide verification, validation, and risk management across multiple disciplines. Onsite work is required.

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