Work mode: Hybrid

Onsite Location(s):Waltham, MA, US, 02138

• Lead a team of system engineers including recruiting, hiring, mentoring, professional development, and performance coaching.
• Develop the system engineering discipline cross functionally through focus on system architecture, interfaces, and a system of systems mindset.
• Oversee and drive the system of system development lifecycle, from design and development to testing, deployment, maintenance, and security.
• Oversee systems requirements development and requirements management tool development.
• Support planning and execution of systems level testing, including manual and automated systems test development.
• Support organizational competency in translating clinical needs to NPD teams.
• Responsible for organizational fluency in key standards for capital equipment and SUD such as ISO 60601.
• Support a high-performing team culture and entrepreneurial environment where people are highly engaged, skilled, and collaborative.
• Help build engagement within the site and team.
• Effectively communicate with different levels of management, as well as business and technical employees.
• Demonstrate effective change leadership.
• Demonstrate ability to succeed in fast paced environment while managing multiple projects simultaneously.
• Deep dive technically where needed while keeping a broad perspective.
• Build strong collaboration with development sites and cross-functional partners.
• 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, and testing.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Keeps the organization's vision and values at the forefront of decision making and action.
• Monitor and ensure compliance with company policies and procedures.
• Travel expectations 25-30%
  
  

• Successful history of launching and maintaining products within the medical device industry
• Demonstrated expertise in systems engineering for the design, development and testing of medical devices.
• Demonstrate a keen interest in EP, workflows, clinical features, and user experience.
• Ability to lead a cross functional site and build engagement.
• Ability to lead a multi-site team and collaborate with peers in different locations.
• Experience working with requirement management, collaboration, and issue tracking tools such as Jama and Jira.
• Working knowledge of hardware, firmware, and software evaluation to standards such as IEC 62304 and ISO 60601
• Lead a group or team of employees in the development and achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Ability to direct and control the activities, budget, and headcount for the systems engineering organization.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• 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 system of systems.