Danaher Corporation Sr. Systems Verification (Test, V&V) Engineer in Sunnyvale, California
The Sr. Systems Verification Engineer is responsible for the development and validation of new molecular diagnostic platforms, with elements related to hardware, consumables, software, and assay interoperability, with the goal of achieving overall system performance requirements for Cepheid’s diagnostic platforms. In this hands-on role, you will work with Biotechnology R&D, Failure Investigation, Firmware, Mechanical, Optical, and Electrical Engineering, Software, NPI, Consumables, and other interdisciplinary groups to design, refine, and test various instrument components/systems for in vitro diagnostic projects. This role is responsible for the planning, execution, analysis, and reporting of system verification experiments in support the development and sustainment of new and current Cepheid molecular diagnostics systems. The ideal candidate will have an engineering background with additional experience working in biological settings in a regulated, medical device environment.
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Essential job responsibilities:
Leads a multi-functional team comprising junior and senior engineers from diverse skill sets (Mechanical, Electrical, Optical, Firmware) to design, test, and validate a new highly spatially multiplexed instrumentation platform, ensuring performance and compatibility with assay products
Responsible for the verification and validation of new systems and leads solving activities at the interfaces of firmware, software, consumables, assays, and hardware
Supports Bio R&D core team in activities related to assay optimization, fluidics development, assay system integration, troubleshooting, and failure analysis
Develops an experienced technical understanding of our products and is capable of hands-on triaging of all Cepheid systems and subsystems
Identifies product functionality gaps and collaborates with internal and external teams to support solution implementation
Works closely with systems engineering functions to ensure products in development are tested against design input requirements, are safe for users and patients, and are thoughtfully evaluated for risks and issues throughout an iterative development process. Relays findings articulately and quickly to develop and design teams.
Accountable for the design and development of test methods and test protocols specific to system verification within NPD and VAVE efforts
Executes test reviews, gap analyses, and data reviews; responsible for development of product test plans, schedules, allocation of resources, prioritization of activities, and project tracking
Participates on Core Teams in new product development to plan verification efforts, execute verification activities, and report out on observations in data reviews
Works independently in a cross-disciplinary environment to plan and execute experiments using niche test equipment; performs experimental data analysis
Supports and leads problem resolution efforts with multi-functional teams
Embodies the core value of continuous improvement to review and optimize current testing and verification practices
Communicates effectively across functions; collaborates with other teams to come up with creative solutions to meet timelines
Education and Experience (in years):
Bachelor’s degree in field with 5+ years of related work experience OR
Master’s degree in field with 3+ years of related work experience OR
Doctoral degree in field with 0-2 years of related work experience.
Bachelor’s degree or equivalent in a relevant field such as Bioengineering, Biomedical Engineering, Systems Engineering, or Test Engineering
Shown basic laboratory skills, including pipetting and reagent handling techniques
Knowledge and skills:
Must have experience with developing and integrating complex instrumentation systems which incorporate optical, mechanical, thermal, and firmware components
Extensive data analysis expertise and experience with various data analysis and programming tools such as Origin, Matlab, R, Python, Mathematica, Minitab or other
Well-developed mathematical and statistical analysis skills
Strong integration analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, solve, and resolve system interoperability problems
Experience with Polymerase Chain Reaction (PCR) or other biological applications of fluorescence
Medical device and/or in vitro Diagnostic product launch experience
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
Operating Company: Cepheid