Staff Systems V&V Engineer

Job Posted 1/24/2023
Bio-Rad Laboratories, Inc.
5731 W. Las Positas Blvd
Pleasanton, CA 94588
United States
Category BioTech
Job Description

Bio-Rad is looking for an enthusiastic Systems Engineer to join the fast-growing Digital Biology Group of Bio-Rad based in Pleasanton, CA. The Digital Biology Group is a multidisciplinary team focused on developing innovative products using our core partitioning technology. Our ddPCR and ddSeq systems have enabled scientists around the world to make impactful discoveries in the life sciences and healthcare. Our mission is to continue creating and providing new tools to scientists that will facilitate more discoveries and advances in research. Within this organization we have an immediate need for a Senior Systems Verification and Validation Engineer to fill a key position focused on the verification and validation of cutting-edge droplet digital PCR systems. You will report directly to the Head of Systems Integration and Verification and be part of a larger multi-disciplinary R&D team. Come join us and be a key player in our next innovative instrument. The work will span from the research stage through product launch. At our DGB R&D center, you can have big company impact while working at a small, nimble and dynamic site.

How You’ll Make An Impact:

  • Applies system engineering principles to develop cost-effective, reliable, high-quality systems that satisfy customer needs and drive business strategies. 

  • Establish design verification & validation plan for a product in development. 

  • Review requirements from a verifiability/testability standpoint. 

  • Lead verification personnel in the development of verification protocols against product requirements and coordinate cross functional reviews on protocols prior to execution. 

  • Lead validation personnel in the development of validation protocols against customer requirements and coordinate cross functional reviews on protocols prior to execution. 

  • Leverage system architecture to avoid duplication of effort between system and subsystems and impact analysis to manage regressions. 

  • Author design verification and validation reports. 

  • Design, create test fixtures and author assembly, operating instructions for test fixtures. 

  • Coordinate development of test tools to simulate errors/faults and acquire objective outputs. 

  • Ensure trace matrices from requirements to specifications to verification to validation are complete. 

  • Support failure analysis efforts through basic experiment planning, execution, documentation, and reporting. 

  • Work closely with Systems Engineers, Instrument Engineers, Assay Developers and Software Developers in all aspects of product development. 

  • Communicate results effectively, guiding the team through data and observations on critical design decisions. 

  • Champion and mature the system design verification and validation process.

What You Bring:

Minimum Qualifications: 

  • Bachelor’s degree or equivalent in a related engineering discipline. 

  • 8+ years of commercial experience developing and Sustaining Platforms for Analytical Applications is Required 

Preferred Qualifications: 

  • PhD in Electrical/Mechanical/Chemical Engineering or Equivalent is desirable. 

  • Experience with Systems Architecture Design, Technology Development, and Systems Integration with Microfluidic or Flow-cytometry Instruments is Highly Desirable. 

  • Demonstrated skill in applying Risk Management, Usability and Reliability tools and practices, expertise, and methodologies to deliver complex programs. 

  • Knowledgeable in ISO 13485 Medical Device Quality Management System Requirements. 

  • Knowledgeable in ISO 14971. 

  • Knowledge of manufacturing and process development activities such as qualification, validation, design of experiments (DOE), and FMEA. 

  • Working Knowledge of Statistics, DOE, DFSS, and/or Signal Processing Algorithm Optimization is Desirable. 

  • General Knowledge or Experience with Molecular Biology, Immunology, or Biological Sciences is Desirable.

Vaccination Requirement: Ability and consent to upload proof of completed Covid-19 vaccination into our secure database within 3 days of start date.  


Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.


Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.  


Benefits: Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, affordability, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer rich options, including no-cost medical plans, free HSA money, a new fertility offering with stipend, life and disability, paid parental leave, 401k plus profit sharing, employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges, time off, ERG’s, and more!  


Compensation: The estimated base salary range for this position is $127,000 to $174,700 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.


EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.  


Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.