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 an experienced Systems Engineer to fill a key position focused on the development and commercialization of cutting-edge in-vitro diagnostics platforms.
• You'll work as part of a cross-functional team as the Subject Matter Expert on all Systems Engineering-related matters from concept and architecture through development and commercialization including:
• Design input requirements and specifications
• FMEAs and Risk Management
• Driving alignment between subsystem plans and design input requirements
• Usability evaluation plans and testing to meet international standards
• System safety risks to comply with ISO 14971
• Verification and Validation design and execution
• Design for Reliability and achievement of platform reliability goals
• You'll work closely with your manager to drive and expand the functional excellence of the entire team through mentorship and training.
• Bachelor's degree in Engineering (Mechanical, Electrical/Electronics, Biomedical). Master's degree preferred.
• 5+ years' systems engineering experience leading and supporting multidisciplinary teams, external development partners, and manufacturing partners.
• Strong background in system design and validation of complex medical devices (programmable electromechanical systems). IVD experience preferred.
• Experience working in FDA regulated environment with knowledge of 21 CFR 820 Part 11 is required.
• Knowledge of FDA QMS requirements, ISO-13485, European Medical Device Regulations and Canadian Medical Devices Regulations.
• Experience with hardware and software interfaces, as well as the hardware and software architecture, is required.
• Knowledge of PLC tools such as JAMA is required.
• Knowledge of Agile principles of hardware engineering is preferred.
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.
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