•Drive cross functional project teams and work as a subject matter expert evaluating, architecting, developing and commercializing new in-vitro diagnostic instrumentation. •Develop System Requirements and technical specifications consistent with company guidelines, and regulations and manage the subsystem extrapolations of those requirements. •Lead the development of ICDs, FMEAs, HMI specification and System risk file. •Work with subsystem design engineers to define requirements and drive alignment between subsystem plans and Product Requirements. •Work with design engineers to Identify and control interfaces to internal components. •Manage system safety risks in compliance with ISO-14971. •Establish a common understanding among team members on technical approach, scope, and risk. •Lead system verification and validation testing design and execution to ensure product performance meets requirements. •Design Integration testing and roadmap in collaboration with Project Management to ensure successful adherence to time management and key milestones. •Manage key external resources to ensure compliance and expectations.
What you need for this role:
•Bachelor’s degree in Engineering (Mechanical, Electrical/Electronics, Biomedical). Master’s degree preferred. •Ability to effectively communicate and translate across functions including engineering, marketing, SW, Regulatory and other global teams. •Must have a high level of self-discipline, drive, and a proven ability to lead teams. •Ability to integrate global standards and regulations into design. •10+ years systems integration experience leading multidisciplinary teams including but not limited to design engineering, requirements, development and implementation, and hardware and software development and integration. •Strong background in system design and validation of complex medical devices (electromechanical devices with control software) 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 and Canadian Medical Devices Regulations. •Experience with HW and SW interfaces, as well as the HW and SW architecture is required. •Design transfer and production ramp-up experience is desirable. •Experience with system testing processes and tools is preferred. •Agile product development experience including HW engineering is greatly preferred. •Willingness and ability to travel domestically and internationally up to 20% of the time.
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 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 pr...oducts that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.