Manager, Systems Engineering
- 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.