Lead System Engineer

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ZAP Surgical Systems, Inc. provided pay range

This range is provided by ZAP Surgical Systems, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$180,000.00/yr - $220,000.00/yr

About the Company

ZAP Surgical Systems is a pioneering surgical robotics company based in San Carlos, CA. Our flagship product, the ZAP-X, utilizes a revolutionary gyroscopic motion platform and a self-shielded design, disrupting conventional radiosurgery and enabling advanced care in new clinical settings. At ZAP, innovation happens at the intersection of diverse disciplines. You’ll join a collaborative, mission-driven team committed to developing the most advanced stereotactic radiotherapy technologies in the world.

Purposes of Position

As a highly motivated and experienced Systems Engineer, you’ll join our innovative medical device team focused on advancing the field of stereotactic radiotherapy. In this role, you will both lead the team as well as serve as a vital link between clinical needs and technical solutions, helping to define the processes while driving the development, integration, and verification of cutting-edge radiotherapy systems.

Ideally, you have a strong background in radiation therapy, with prior experience as a dosimetrist or in a related RT clinical role (Medical Physicist or Radiation Therapist). You’ll play a key role in translating clinical workflows user needs into testable requirements and ensuring our products meet the highest standards.

Major Duties

• Lead and mentor a team of systems engineers working on the full lifecycle of complex radiotherapy systems.
• Act as the primary systems engineering contact on key projects, particularly for the Treatment Planning System application.
• Requirements: Translate clinical and user needs into clear, testable software requirements.
• Risk Management: Partake in risk analyses (e.g., FMEA) for software systems and implement mitigation strategies in accordance with medical device standards.
• Verification and Validation: Develop test plans, protocols, and acceptance criteria. Ensure traceability from requirements to test outcomes.
• Documentation: Create and maintain comprehensive technical documentation including specifications and regulatory submissions.
• Expertise: Guide clinical workflow and product implementation to meet regulatory compliance and the needs of the radiotherapy field.
• Troubleshooting & Analysis: Operate the system and lead investigations into system-level issues; design and perform engineering tests as needed.
• Collaboration: Work closely with clinical, engineering, quality, regulatory, manufacturing and service.
• Standards & Regulations: Stay up to date with relevant industry standards (IEC 60601, ISO 13485).

Qualifications

• Education Requirements: Bachelor’s or Master’s degree in Engineering, Computer Science, Physics, Biomedical Engineering or related field.
• Minimum of 5 years of relevant industry experience.
• Experience with requirements management tools and the systems process
• Experience developing and managing Verification and Validation procedures.
• Experience in the regulated medical devices environment, including document control processes.
• Prior experience with robotics systems or medical devices.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communications.
• Willingness to work in a startup environment and adapt to changing needs and priorities.

Preferred Qualifications

• Understanding of radiation therapy principles and clinical workflows.
• Background in team leadership.
• Experience with medical imaging software, treatment planning systems (TPS), or radiotherapy equipment software.
• Experience with full product development lifecycle in a regulated industry.
• Clinical experience as a Dosimetrist, Medical Physicist, or Radiation Therapist is a bonus.
• Python or Matlab for scripting and data analysis or other programming language.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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