Sr. System Engineer

Planet Pharma; Burlington (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Planet Pharma is seeking a Senior System Engineer to join our R&D team. The role is hands-on and execution-focused, supporting system development, integration, verification, and sustaining activities for complex electromechanical medical devices.

You will work closely with hardware, software, firmware, mechanical, quality, and regulatory teams to ensure system requirements are implemented, integrated, and verified, with a strong emphasis on cross-functional collaboration.

Qualifications

• Bachelors degree in electrical engineering or related field; advanced degree preferred.
• 5+ years in system engineering within the medical device industry.
• Experience architecting, integrating and verifying complex electrod mechanical devices.
• Hands-on experience with system integration, testing and troubleshooting.
• Experience with Helix or Jama for requirements management.
• Knowledge of regulatory standards such as 60601-1, 60601-2, 60601-1-6.
• Strong cross-functional collaboration and communication skills.
• Detail-oriented with strong analytical/problem-solving abilities.

Responsibilities

• Design and manage system requirements, allocation and traceability.
• Assist with system architecture definition and interface management.
• Maintain system documentation and design artifacts.
• Develop and maintain test fixtures for boards and subsystems.
• Support system integration, verification and validation activities.
• Coordinate ECOs and lifecycle updates using Oracle and Veeva.
• Collaborate with hardware, software, firmware, mechanical, quality and regulatory teams.
• Support risk management activities including FMEA updates.

Skills

System engineering

Requirements management

V&V

Test and debugging

Problem solving

Cross-functional collaboration

Education

Bachelors degree in Electrical Engineering or related field

Advanced degree preferred

Tools

Helix

Jama

Oracle

Veeva

Job description

Position Overview:
We are seeking a highly skilled, self-motivated and experienced Senior System Engineer to join our R&D team. The successful candidate will supports system development, integration, verification, and sustaining activities for a complex electromechanical product. This role is hands‑on and execution-focused, working closely with hardware, software, firmware, mechanical, quality, and regulatory teams to ensure system requirements are implemented, integrated, and verified.
The ideal candidate can quickly ramp up, contribute immediately, and support active development and integration efforts.

Responsibilities:

Design and requirement management

• Support system-level requirements for development, allocation, and traceability in Helix or Jama.
• Assist with system architecture definition and interface management across hardware, software, firmware, and mechanical domains
• Maintain and update system documentation, including requirements, specifications, and design artifacts
• Design, set up, and maintain test fixtures for boards and subsystem validation.
• Develop and maintain mechanical and electrical documentation packages for test Fixtures, including drawings, schematics, and test reports.

System Integration

• Execute and support system integration of hardware, software, and firmware components at subsystem and system levels
• Support Verification and Validation (V&V) by defining, specifying, and supporting testing, analysis, and integration activities
• Actively participate in system bring-up, integration testing, and debugging
• Develop a strong understanding of end-to-end system performance and behavior
• Collaborate with Subject Matter Experts (SMEs) to investigate, troubleshoot, and drive resolution of system-level issues during development and integration
• Provide timely technical feedback to support issue resolution and project schedules

Verification, Validation, and Documentation

• Develop and support system test plans, protocols, and procedures
• Execute or support system-level testing and data analysis
• Conduct testing on both the system and subsystem levels, including bench tests, simulations, and clinical evaluations, Engineering Prototypes etc.
• Ensure test reports and integration reports are prepared to document results, findings, and compliance status
• Support issue investigation, root cause analysis, and corrective actions

Lifecycle and Change Management

• Manage engineering change orders (ECOs) and lifecycle updates through digital platforms such as Oracle and Veeva
• Ensure accurate documentation, review coordination, and timely implementation of approved changes
• Support configuration control by ensuring system documentation reflects released and implemented changes
• Collaborate with cross-functional teams to assess system-level impact of changes on requirements, verification, and compliance

Cross-Functional & Compliance Support

• Work closely with hardware, software, firmware, mechanical, quality, and regulatory teams
• Support risk management activities, including hazard analysis and FMEA updates
• Assist with design control and compliance documentation as required
• Support internal and external audits, reviews, or assessments as needed

Risk Management:

• Support hazard analysis and risk assessments (e.g., Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA)) to identify potential risks. Work to minimize risks through design controls, redundancy, and safety mechanisms.

RequirementsQualifications:

• Bachelor’s degree in electrical engineering or related field; advanced degree preferred.
• 5+ years of experience in system engineering within the medical device industry, with a focus on complex electro‑mechanical devices.
• Demonstrated success as an engineering team member in the architecture, system level design, integration and verification of complex electro‑mechanical devices.
• Experience with complex electromechanical systems
• Strong understanding of system verification and validation
• Hands‑on experience with system integration, testing, and troubleshooting
• Experience of utilizing the requirement management tools such as Helix, Jama etc.
• Development experience in at least one or more of the following engineering disciplines is required: software, mechanical, electrical, optics, and should possess knowledge of advanced theories, concepts, principles, and processes.
• Understanding of regulatory standards and requirements, particularly 60601-1, 60601-2, 60601-1-6 and other relevant compliance and safety standards, preferred.
• Ability to work effectively across different functions and with external partners to drive project success.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross‑functional teams.
• Detail‑oriented with strong analytical and problem‑solving abilities.