Principal System Engineer I

Roche • Pleasanton, CA

1d • Onsite

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position We are seeking a highly motivated Principal System Engineer I to join our End-to-End Solution Integration Chapter supporting Next-Generation Diagnostic Solutions. In this hands-on role, you will drive feasibility, development, and integration of complex multi-disciplinary systems spanning sample preparation, library preparation, molecular detection technologies (e.g., digital PCR, sequencing by synthesis, microarray), and bioinformatics/data processing pipelines. You will collaborate with assay, software, hardware, and bioinformatics teams to define, integrate, and optimize system-level performance, ensuring technical robustness and operational scalability across diverse technologies. This role is ideal for a systems-minded engineer with direct industry experience in sequencing workflows, strong analytical and statistical skills, and the ability to influence cross-functional projects without formal people management responsibilities. The Opportunity You will oversee 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 complex hardware and software issues. Characterize, optimize, and set subsystem specifications to ensure the system meets all design inputs. Ensure system designs, integrations, and troubleshooting documentation meet stringent quality standards for IVD products, while maintaining the agility needed for rapid RUO development. Partner with assay, software, and bioinformatics teams to ensure the seamless integration of sequencing output with downstream analysis pipelines. You will provide 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 You will collaborate & 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. This is an onsite position based in Pleasanton, CA. (This is not a hybrid position.) Relocation support is not provided for this role.

Requirements

• You have a PhD in Systems Engineering, Bioengineering, Biomedical Engineering, Electrical Engineering, Computer Science or a related field with 3+ years of relevant industry experience; or a Master’s in Systems Engineering, Bioengineering, Biomedical Engineering, Electrical Engineering, Computer Science or a related field with 5+ years of relevant industry experience; or a Bachelor’s in Systems Engineering, Bioengineering, Biomedical Engineering, Electrical Engineering, Computer Science or a related field with 7+ years of relevant industry experience.
• You have 2+ years of experience developing molecular diagnostic-related products.
• You have demonstrated experience with physical teardowns and reassembly of instruments; you have the ability to inspect, test, and debug circuit boards, sensors, and physical components to identify root causes of failures.
• You have a demonstrated level of understanding of the physical and software designs behind automated life science instruments.

Nice To Haves

• You have an advanced degree.
• You have proven lab troubleshooting experience with instrumentation used in sequencing and/or PCR-based workflows
• You have strong problem-solving skills with the ability to work independently
• You have excellent written and verbal communication skills to effectively influence cross-functional stakeholders.
• You have experience across multiple product life-cycle stages.
• You have experience developing and supporting In Vitro Diagnostic (IVD) products under ISO 13485 / FDA regulations. (Highly relevant Research Use Only (RUO) experience in NGS or dPCR will be considered.)
• You have demonstrated experience with scripting/programming experience for automation or data analysis

Responsibilities

• 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 complex hardware and software issues.
• Characterize, optimize, and set subsystem specifications to ensure the system meets all design inputs.
• Ensure system designs, integrations, and troubleshooting documentation meet stringent quality standards for IVD products, while maintaining the agility needed for rapid RUO development.
• Partner with assay, software, and bioinformatics teams to ensure the seamless integration of sequencing output with downstream analysis pipelines.
• 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
• 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.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree