Senior Systems Engineering Manager - Electrophysiology

About the position

The Systems Engineering Senior Manager will provide leadership, vision, and direction within the EP systems engineering organization. In the role of Senior Manager, you will be responsible for supporting the growth and continued development of the Systems Engineering team and function; overseeing technical staff members and helping to define and foster functional excellence. You will have the opportunity to significantly impact the development of truly life changing patient therapies for the relief of debilitating diseases.

Responsibilities

• 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%

Requirements

• 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.

Benefits

• 401k
• health_insurance
• dental_insurance
• vision_insurance
• life_insurance
• disability_insurance
• tuition_reimbursement
• paid_holidays
• paid_volunteer_time
• employee_stock_purchase_plan
• professional_development
• flexible_scheduling