Principle Systems Engineer II

Roche; Santa Clara (CA); Hybrid; USD 127,000 - 237,000; Full time

Job summary

Roche seeks a Principal Systems Engineer II in Santa Clara to lead verification and validation for next-gen sequencing platforms. You will matrix-manage cross-functional teams across hardware, software, firmware, and chemistry interfaces, driving advanced test engineering and risk management.

Qualified candidates have a strong NGS background, experience with regulatory standards, and a track record in delivering complex medical device verification programs.

Qualifications

• 10 years of related experience or MS + 9 years; or PhD + 6 years.
• Experience leading full-scale verification campaigns.
• Deep NGS, molecular diagnostics background.

Responsibilities

• Lead V&V campaigns across cross-functional teams for complex NGS platforms.
• Draft, review, execute test cases; diagnose issues with stakeholders.
• Evaluate design concepts for requirements coverage and risk.
• Serve as SME for complex instrument troubleshooting and compliance.
• Mentor junior engineers and influence acrossQuality, Regulatory, Ops, and ITS.
• Oversee environmental chamber studies and EMC/EMI testing with partners.
• Own DHF deliverables and Installation/Operational Qualification docs.

Skills

V&V leadership

Systems engineering

NGS platforms

Regulatory compliance

Risk management

Mentorship

Education

MS in related discipline

PhD in 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

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

Benefits

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

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.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.