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R and D Systems Director
Location:
Waltham, MA
Description:
Additional Location(s): N/A Diversity : Innovation : Caring : Global Collaboration : Winning Spirit: High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high:performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing : whatever your ambitions. Purpose Statement: The Systems Director will provide leadership, vision, and direction for the EP R and D Systems Engineering organization. Responsible for strategic team leadership, driving system of system methodology, synthesis of system architecture and systems requirements/ verification. Responsibilities: :Experience leading and growing a system engineering team including recruiting, hiring, mentoring, professional development, and performance coaching. :Develop the system engineering discipline cross functionally through focus on system architecture and a system of systems mindset. :Oversight of Systems Requirements development and requirements management tool development :Creation of organization competency in translating clinical needs to NPD teams. :Leadership of planning and execution of systems level testing, including test manual any automated systems test development. :Responsible for organizational fluency in key standards for capital equipment and SUD such as ISO 60601. :Participates in cross functional franchise level leadership (planning and execution) :Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. :Creates an entrepreneurial environment. :Provides general direction to managers, exempt specialists and non:exempt support in various areas, groups and/or operations. :Keeps the organizations vision and values at the forefront of decision making and action. :Demonstrates effective change leadership. :Builds strategic internal and external partnerships to further departmental and organizational objectives. :Cultivate a culture of continuous improvement by staying informed about industry trends, technological advancements, and emerging tools in medical device systems engineering, human factors, design controls, reliability testing, and software development. :Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.). :Directs and controls the activities and budget of one or more functional areas, divisions, product groups and/or operations. :Makes and executes operational decisions with a strategic perspective. :Travel expectations 25:30 Requirements: stylemargin:bottom:13.0px::Successful history of launching and maintaining products within the medical device industry :Demonstrated expertise in design, development and testing of software based medical devices. :Working knowledge of hardware, firmware and software evaluation to standards IEC 62304, 60601:1:8, 21CFR Part 11 and ICH E6 Good Clinical Practice. :Experience working with requirement management, collaboration and issue tracking tools such as Jama, and Jira at the customization level. :Significant experience working with agile software development methods such as Scrum. :Experience with cyber security and privacy policies and design requirements. :Experience with performance and reliability test strategies and tools. :Bachelor of Science degree in a relevant engineering discipline with 10+ years of experience developing highly complex systems :5+ years' experience managing technical teams in the development of medical device software. :Leads a group or team of employees in the development and achievement of organizational goals. Guide, coac
Industry:
Insurance
Posted:
May 8 on Tip Top Job
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More About this Listing: R and D Systems Director
R and D Systems Director is a Executive Director Job located in Waltham MA. Find other listings like R and D Systems Director by searching Oodle for Executive Director Jobs.
R and D Systems Director is a Executive Director Job located in Waltham MA. Find other listings like R and D Systems Director by searching Oodle for Executive Director Jobs.