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Staff Systems Engineer

Element Science· Engineering
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Redwood City, CA$175k - $185kfull-timePosted 3w ago

About the role

Senior role leading system architecture, requirements definition, design development support, systems integration, and verification/validation across the product lifecycle for sustaining, product iteration, and next-gen initiatives in a medical device/wearable patch defibrillator company.

Responsibilities

  • Lead requirements definition of system, subsystem, interface requirements and supporting definition of design outputs with cross-functional teams (R&D, quality, regulatory, clinical, user experience, manufacturing, etc)
  • Lead data analysis on product performance and propose data driven solutions to complex system-level performance and technical issues inclusive of hardware, firmware, algorithm, signal processing, and manufacturing
  • Performs investigation and root cause analysis for field and manufacturing issues
  • Lead design change impact analysis and regression test plans
  • Plan and lead system-level characterization testing and verification & validation testing including protocol and report documentation as well as coordination and execution of internal testing and managing external standards compliance testing as needed
  • Lead multi-disciplinary projects, ensuring scope, schedule and deliverables are met
  • Lead technical and design reviews to present data analysis, project tradeoff studies, drive decisions, and align cross-functional teams
  • Maintaining requirements and verification and validation traceability
  • Support risk management, System Hazard Analysis, and dFMEAs. Identification of risks and proposal of risk-based decisions
  • Maintains up-to-date knowledge of medical devices and technologies related to the company’s products
  • Provide peer review of designs and documentation. Mentor junior engineers as the team grows.

Qualifications

  • BS in Electrical, Mechanical, Biomedical, or Software Engineering. Advanced degree preferred (Electrical Engineering preferred)
  • 10+ years of experience in product development of electro-mechanical systems with strong medical device experience
  • Successful track record of defining, developing, testing, and troubleshooting electro-mechanical, firmware and software systems to serve as systems engineering subject matter expert across cross functional teams
  • Demonstrated ability to independently drive projects with rigorous system-level performance analysis with strong technical judgment to guide product design and project decisions
  • Outstanding communication across different stakeholders, departments, and experience levels to drive collaboration, alignment, resolve blockers, and achieve project objectives
  • Experience with requirements management and traceability tools
  • Proficiency in data analysis, processing, visualization, and statistical tools such as: MATLAB, Python, Excel, Minitab etc.
  • Strong working knowledge of relevant standards to ensure designs meet compliance (e.g. IEC 60601, ISO 10993, IEC 62304, ISO 14971)
  • In-depth experience with QMS, medical product development processes, and design controls

Skills

Required:System requirements management and traceabilityData analysis and interpretationRoot cause analysis

Benefits

  • Stock Options
  • 90% employer-paid medical, dental, and vision insurance
  • Company-paid Basic Life Insurance
  • 401(k) retirement plan (Traditional and Roth)
  • Competitive Paid Time Off
  • Paid Holidays
  • FSA (Flexible Spending Accounts)
  • HSA (Health Savings Account)
  • Employee Assistance Program through PEO
Last updated Oct 9, 2026. Interested? Apply on the company site.

About Element Science

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