Senior Staff Instrument Verification Engineer

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 Sr. Staff Instrument Verification Engineer to fill a key position focused on the verification of cutting-edge in-vitro diagnostics systems.

Responsibilities

• Lead Instrument Verification test planning, test method development and execution. 
• 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. 
• 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. 
• Lead/mentor test team members to utilize advanced testing methods where necessary, such as (but not limited to): strain gage, load cell and other sensor/transducer instrumentation, accelerometer data collection/processing, accelerated life testing, DoE etc.
• Ensure trace matrices from requirements to specifications to verification to validation are complete. 
• Lead/mentor the test team members in the design and development of manual and automated test solutions at a system level and sub-system level to support the testing of robotic and electromechanical assemblies. 
• 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. Work on integration of sub-assemblies. • 
• Communicate results effectively, guiding the team through data and observations on critical design decisions. 
• Present Test Plans, Strategy, Data, Analysis, Findings and Recommendations to broader organization including leadership at Bio-Rad. 
• Champion and mature the instrument design verification and validation process.

Qualifications

Minimum Qualifications: 

• Bachelor’s degree or equivalent in a related engineering discipline. 
• 10+ years of experience or equivalent combination of education and experience. 
• Ability to create, read electrical schematics and mechanical assembly drawings as well as understand their functions. 
• Experience designing electromechanical assemblies and automated test fixtures including data acquisition systems. 
• Knowledge of and application of principles and theories of engineering. 
• Strong communication, technical, and computer skills. 
• Coordination, tact, and teamwork. 
• Manual dexterity. 

Preferred Qualifications: 

• System level V+V experience across instruments, chemistry, and software. 
• Experience in AutoCad, ProE, Solid Works, Altium and/or Orcad. 
• Advanced Experience with any of C++, C#, National Instruments SW, Python. 
• Ability to independently review and approve engineering analyses, test plans and reports by junior team members. 
• Demonstrated understanding of engineering process, statistical and analytical methods and reliability analysis, FMEA, Design of Experiments (DoE). 
• 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. 
• Design for Six Sigma experience

Vaccination Requirement:

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.

About Bio-Rad: 

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.

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Agency Non-Solicitation: 

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