Bio-Rad Clinical Diagnostics Group (CDG) is one of the leading global providers of tests for infectious and autoimmune disease screening, diabetes screening and monitoring, blood grouping as well as a range of reagents and software for laboratory quality control. CDG provides over 3,000 reagents, devices, and instruments for about 300 diagnostic tests to a global customer base. At Bio-Rad CDG we are building a world class global R&D capability to support our ambitious clinical diagnostics strategy and drive long term growth for the company. An important part of this transformation is the creation of a Global Systems Engineering Organization to support our existing core diagnostics platforms and to execute an exciting new product roadmap. Within this organization we have an immediate need for a Staff Systems Verification and Validation Engineer to fill a key position focused on the verification and validation of cutting-edge in-vitro diagnostics systems.
- Establish master 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.
- 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.
- Bachelor’s degree or equivalent in a related engineering discipline.
- 8+ years of experience or equivalent combination of education and experience.
- Advanced knowledge of and application of principles and theories of engineering.
- Strong communication, technical, and computer skills.
- Coordination, tact and teamwork.
- Manual dexterity.
- System level V+V experience across instruments, chemistry and software.
- Technical background that can be applied to hardware, software and chemical design/development.
- Experience translating requirements documents into test cases, assigning test methods.
- Knowledgeable in ISO 13485: 2016 (or latest version) Medical Device Quality Management System Requirements.
- Knowledgeable in ISO 14971.
- Knowledgeable in FDA 21 CFR part 820 Quality System Regulations.
- Knowledge of manufacturing and process development activities such as qualification, validation, design of experiments (DOE), and FMEA.
- Proven ability to set and execute priorities in a timely manner.
- Proven determination and resourcefulness to carry out complex projects through completion.
- Demonstrated excellent oral and written communication, collaboration, and presentation skills.
- Ability to work both as an individual contributor and as a key member of the team.
Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad has a mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. New hires will be asked to upload their vaccination card into our electronic database hosted by ClearPass, who specializes in securing electronic medical information, within 3 days of their start date. With this policy, Bio-Rad joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of its employees and the community.
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
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. #LI-AK1 #LI-Hybrid