Principle Systems Engineer II

F. Hoffmann-La Roche AG; United States; Hybrid; USD 127,000 - 237,000; Full time

Job summary

Roche is seeking a Principal Systems Engineer II in Santa Clara to lead system verification efforts for next-generation sequencing platforms. You will matrix-manage cross-functional teams spanning hardware, software, firmware, and chemistry interfaces.

The role requires extensive V&V, design assessment, and risk management, with mentoring across QA, Regulatory, and Operations. Hybrid schedule 3-4 days on campus; salary disclosed as CA range; prior AI-assisted testing experience a plus.

Qualifications

• 10 years of related experience OR MS degree +9 years OR PhD degree +6 years
• V&V & Compliance Experience: Demonstrated success leading full-scale system verification campaigns
• Systems Engineering Mastery: End-to-end systems engineering, architecture, interfaces
• Domain Expertise: NGS platforms, molecular diagnostics, nucleic acid-based technologies
• Tooling & Risk Management Standards: HPALM, RETINA, ISO 14971, FMEA/PFMEA
• Preferred AI-assisted test automation experience
• IVD submission environments and regulatory interaction

Responsibilities

• Lead cross-functional V&V campaigns for complex NGS platforms
• Draft, review, and execute test cases; diagnose and resolve issues
• Evaluate design concepts for requirements coverage, feasibility, and reliability
• Serve as SME for troubleshooting, non-compliance resolution, and issue translation
• Mentor junior engineers; influence across Quality, Regulatory, Operations
• Oversee environmental chamber studies and EMC/EMI testing with partners
• Write DHF deliverables, IOQ procedures, and installation guides

Skills

V&V Leadership

Systems Engineering

AI-assisted test automation

Cross-functional collaboration

Education

MS degree in a related discipline

PhD degree in a related discipline

Tools

HPALM

RETINA

Job description

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 A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

The Opportunity

As a Principal Systems Engineer II within our System Development & Integration team, you will serve as a key technical leader and Subject Matter Expert (SME) driving the systems engineering, integration, compliance, and verification efforts for our next-generation sequencing (NGS) platforms. In this role, you will matrix-manage cross-functional verification teams and navigate complex system dynamics across hardware, software, firmware, and chemistry/assay interfaces.

Key Responsibilities

• V&V Campaign Leadership: Direct and matrix-manage cross-functional Verification & Validation (V&V) teams, leading the end-to-end execution of functional verification campaigns for complex NGS platforms.
• Advanced Test Engineering: Lead the drafting, reviewing, dry-running, and execution of test cases, in front of the sequencing solution. Diagnose issues identified and work with stakeholders to resolve them, while driving the adoption of innovative tools such as AI-driven test case generation.
• Architectural & Design Assessment: Evaluate and critique design concepts for requirements coverage, feasibility, reliability, modularity, risk, and serviceability early in the platform lifecycle.
• Root Cause Analysis: Serve as the primary technical escalation point and SME for complex instrument troubleshooting, non-compliance resolution, and system-level issue translation.
• Mentorship & Cross-Functional Influence: Mentor junior systems engineers and technicians while serving as a strategic technical voice across Quality, Regulatory, Operations, and International Technical Services.
• Compliance & Specialized Testing: Oversee multi-site environmental chamber studies and hardware compliance testing, including EMC/EMI testing with third-party partners (e.g., Intertek).
• Technical Documentation & DHF Ownership: Establish, manage, and write Design History File (DHF) deliverables, Solution-Level Installation Guides, and Installation/Operational Qualification (IOQ) procedures.

Who you are (Required)

Education & Experience: 10 years of related experience OR, MS degree in a directly related discipline + 9 years of related experience required; OR required, PhD degree in a directly related discipline + 6 years of related experience required.

V&V & Compliance Experience: Demonstrated success leading full-scale system verification campaigns, environmental chamber studies, and diagnosing issues identified.

Systems Engineering Mastery: Proven expertise in end-to-end systems engineering processes, including architecture development, interface definition, error budgeting, Ad-Hoc Testing & Troubleshooting.

Domain Expertise: Deep hands-on background in Next-Generation Sequencing (NGS) platforms, molecular diagnostics, and nucleic acid-based technologies.

Tooling & Risk Management Standards: Proficiency with requirements management tools (e.g., HPALM, RETINA) and medical device risk management standards (ISO 14971, FMEA/PFMEA).

Preferred Demonstrated success leading AI-assisted test automation or advanced test generation methodologies.

Advanced experience in IVD (In Vitro Diagnostics) submission environments and direct interaction with regulatory compliance bodies.

Track record of matrix-managing multidisciplinary engineering teams in high-complexity medical device development.

Location

This role is based in Santa Clara and offers a hybrid schedule working 3-4 days per week on campus. No relocation benefits are available for this posting.

Expected Salary

The expected salary range for this position based on the primary location of CA is $127,300 - $236,500 annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Benefits

This position also qualifies for the benefits detailed at the link provided below.

Accommodations for Applicants. We believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future.

About us

We believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.