Sr. Systems Engineer jobs in United States
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Sharp Decisions ยท 5 hours ago

Sr. Systems Engineer

Sharp Decisions is seeking a highly motivated Senior Systems Engineer for a biotechnology client in Pleasanton, CA. The role involves driving the feasibility, development, and integration of complex multi-disciplinary systems for Next-Generation Diagnostic Solutions, collaborating with various teams to ensure system-level performance and robustness.

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Senior Management
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Responsibilities

Systems Development, Integration & Analysis
Drive system-level development activities across wet lab workflows, instruments, and data pipelines for next generation diagnostic solutions
Perform hands-on system integration and troubleshooting of workflows including sample extraction, library preparation, molecular detections, and data transfer
Partner with assay, software and bioinformatics teams to ensure seamless integration of sequencing output with downstream analysis pipelines
Contribute to system architecture, requirements definition
Apply statistical analysis and Design of Experiments (DoE) methodologies (e.g., JMP, ANOVA, regression) to characterize, optimize, and set subsystem specifications
Verification, Validation & On Market support
Plan, design and execute verification and validation (V&V) test cases to ensure comprehensive coverage of requirements
Analyze test results for accuracy, validity, and relevance to user needs
Support post-launch troubleshooting and field investigations through failure mode and root cause analyses
Collaboration & Influence
Represent Systems Engineering in cross-functional project teams on key topics such as requirements management, defect management, system integration, etc
Collaborate closely with assay scientists, software developers, hardware engineers, and bioinformaticians to align on end-to-end workflows
Contribute to system documentation, including requirements, specifications, integration plans, and verification results
Identify and lead opportunities for workflow simplification, automation, and continuous improvement

Qualification

Sequencing workflowsBioinformatics pipelinesStatistical analysisSystems EngineeringPCR-based workflowsDoE methodologiesAnalytical skillsScripting/programmingCommunication skills

Required

PhD degree with related field with 5+ years of relevant industry experience is highly valued
Masters degree with 10+ years of relevant industry experience
Bachelors degree with 10+ years of relevant industry experience
Hands-on industrial experience with sequencing related workflows, including nucleic acid extraction, library preparation, and sequencing
Proven lab troubleshooting experience in sequencing workflows and PCR-based workflows
Experience with statistical tools and DoE methodologies (JMP, regression, ANOVA) is required
Strong analytical and problem-solving skills with the ability to work independently
Excellent written and verbal communication skills to influence cross-functional stakeholders

Preferred

Exposure to bioinformatics/data processing pipelines for sequencing output (variant calling, data QC) is highly desirable
Familiarity with system-level product development in life sciences instrumentation is a plus
Experience across multiple product life-cycle stages is a plus
Experience in digital PCR platforms is desirable
Experience with developing In-vitro Diagnostic products is desirable
Experience in implementing workflow on semiconductor based sensing devices or microfluidic devices is desirable
Scripting/programming experience (Python, R, or equivalent) is a plus

Company

Sharp Decisions

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Sharp Decisions is a staffing and recruiting company that offers technology and business staffing solutions.

Funding

Current Stage
Growth Stage

Leadership Team

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Karen Ross
Founder, President and CEO
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Stuart Gottlieb
CFO/COO and Principal
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