Senior Systems Integration Engineer

Description

The company develops next generation NGS assays and products for early cancer detection, and this role sits in its Product Development team of scientists and engineers focused on its IVD assay portfolio.

You will lead hands-on systems integration work and technical leadership for a growing group of Systems Integration engineers while still contributing individually. The role reports to the Senior Manager, Systems Integration.

The work is onsite at the company's headquarters in Brisbane, California, and the team must keep pace with fast technological change as it builds its platform.

Responsibilities

• Set the functional integration strategy and run end-to-end assay workflows, system verification, and validation, while staying hands-on with automation platform operation and system-level testing.
• Define study scope, validation approaches, success criteria, and execution plans on your own. Write and run system-level protocols, judge results against user needs, design input requirements, and product requirements, and report conclusions that feed AV/CV and development exit decisions.
• Work with Development, software test engineering, automation, and SLIMS to set test coverage, entry and exit criteria, and deployment risk reduction. Bring qualified software releases into functional integration and run or coordinate lab deployment and fleet-wide configuration checks.
• Lead the system reliability program and its cross-functional core team. Set reliability metrics, track recurring failure modes, rank and triage risks, and make sure owners of each subsystem follow through on mitigations. Lead priority technical investigations and report on improvements, mitigation status, and resourcing needs.
• Assess system performance, find blockers early, determine root causes, and use analytical problem solving to build scalable fixes for prioritized issues in reagents, workflows, automation, hardware, software, and system integration.
• Write and review system requirements, test strategies, validation protocols, traceability records, technical reports, and other design control documents under the design control framework and design history files.
• Act as the subject matter expert for system-level dFMEA, pFMEA, risk management, hazard assessment, and design reviews. Identify hardware, firmware, software, workflow, and process mitigations with the accountable subsystem owners.
• Build cross-functional support by clearly sharing opportunities, risks, needs, problems, proposed fixes, and results in the right forums. Run project debriefs to improve future integration and validation work.
• Guide and mentor SI engineers on study design, hands-on execution, troubleshooting, and documentation, while you keep individual ownership of your own deliverables.

Requirements

• A bachelor's degree with 8+ years of relevant experience, a master's degree with 6+ years, or a doctorate with 3+ years, or equivalent experience.
• A degree or equivalent experience in a relevant field such as biology, biochemistry, bioengineering, biomedical engineering, systems engineering, mechanical engineering, electrical engineering, or a related discipline.
• Hands-on experience developing, integrating, or evaluating NGS assays or NGS-based diagnostics, including automated NGS workflows.
• Experience running hands-on system integration work, including assay workflow execution, automation platform operation, system evaluation, troubleshooting, performance characterization, and verification or validation testing.
• Experience writing and running system-level test plans and protocols, analyzing data, interpreting results, checking requirements conformance, investigating failures, and performing root cause analysis.
• Strong data analysis skills, including statistics and design of experiments (DOE), with tools such as JMP, R, or equivalent. SQL, Python, R, or other programming skills are highly desired.
• Experience analyzing reliability data, spotting recurring failure modes, and driving cross-functional investigations and mitigation follow-through.
• Direct experience in an FDA-regulated, IVD, medical device, diagnostics, or other regulated product development environment.
• Solid working knowledge of requirements management, design controls, risk management, traceability, technical report writing, design history files, and applicable quality system requirements.
• A proven ability to work independently on complex technical assignments, lead key projects, set priorities against company objectives and available resources, guide others technically, and build cross-functional support.

Conditions

Onsite role at the Brisbane, California headquarters.

Reports to the Senior Manager, Systems Integration.

Base salary target range for new hires in the US is $156,750 to $200,025. Final total compensation is set at the company's discretion and depends on location, skill level, depth and years of relevant experience, and education.

Equal opportunity employer that does not discriminate on any basis protected by federal, state, or local law.

Benefits

• Eligibility for equity, cash bonuses, and a full range of medical, financial, and other benefits, depending on the position offered.
• Rights under federal employment laws, including FMLA, EEO, and EPPA, plus CCPA notice for California applicants.