Systems Engineering Manager
Systems Engineering Manager
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.
We are looking for an experienced Systems Engineer to manage a group of engineers focused on the development of cutting-edge in-vitro diagnostics instrumentation. This role will provide the right engineer with the opportunity to build a high-performance team and guide the development of next-generation platforms that will have a long-term impact on the clinical diagnostics industry.
• Provide proactive leadership of the Systems Engineering team in the execution of multi-year instrument platform development and commercialization activities.
• Work with your group as part of a cross-functional team as the Subject Matter Experts 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.
• Define 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.
• Build and cultivate a results-oriented culture of innovation, empowerment, risk tolerance, learning and continuous improvement across the group. Build and maintain effective cross-functional collaborations within Bio-Rad and with external partners.
• Work closely with the R&D and Engineering Leadership teams to drive and continually expand the functional excellence of the entire engineering team through mentorship and training.
• Bachelor's degree in engineering (mechanical, electrical/electronics, biomedical). Master's degree preferred.
• 8+ years' systems engineering experience leading and supporting multidisciplinary teams, external development partners, and manufacturing partners.
• 5+ years in building and managing high-performance engineering teams.
• Strong background in system design and validation of complex medical devices (programmable electromechanical systems). IVD experience including experience with clinical diagnostic assays preferred.
• Experience working in FDA regulated environment with knowledge of 21 CFR 820 Part 11.
• 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 hardware and software architecture, is required.
• Knowledge of lifecycle management tools such as JAMA is required.
• Experience with Design for Reliability preferred.
• Knowledge of Agile principles of hardware engineering is preferred.
• Willingness to travel up to 20% domestically and/or internationally.
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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