Roche · 2 hours ago
Senior Systems Engineer
Santa Clara
Full-time
Onsite
Senior Level
$84K/yr - $125K/yr
5+ years expRoche is a leading company in healthcare innovation, dedicated to providing access to medical solutions. The Senior Systems Engineer will focus on developing novel In Vitro Diagnostics (IVD) automated systems and lead cross-functional teams throughout the product development lifecycle, ensuring compliance with regulatory standards.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
Provide technical expertise to cross-functional teams to develop IVD systems and ensure the product design will meet customer requirements as well as applicable standards and regulations
Develop and manage systems level product requirements
Perform product risk management activities
Develop and execute verification/validation activities and traceability analysis
Create artifacts required for project deliverables
Resolve issues found according to company’s defect/change tracking process
Maintain knowledge of current regulatory requirements and standards as they pertain to the development and testing of medical/IVD devices
Maintain compliance as required by regulatory bodies and the company’s quality system
Collaborate with cross functional teams to identify opportunities for continuous process improvement
Lead and mentor less experienced Systems Engineers
Support U.S. Food and Drug Administration (FDA) and other regulatory submission and audits
Qualification
Required
Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering or related disciplines
5+ years of professional experience in medical device industry
Experience in IVD industry highly desirable
Hands-on experience with liquid pipetting systems such as Hamilton, Tecan etc. is a plus
Experience developing product requirements and design inputs
Experience conducting risk management activities per ISO 1497
Strong analytical, problem solving, communication, and interpersonal skills
Preferred
Advanced degree preferred
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.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and Group Vice President, Computational Science and Informatics R&D
Recent News
2026-01-25
2026-01-23
2026-01-22
Company data provided by crunchbase