The Ascent Group LLC
Job Summary:
Lead large-scale, complex medical product development programs involving internal and external teams. Provide technical leadership in the design, testing, and integration of medical devices, ensuring compliance with regulatory standards. Drive project planning, execution, and risk management while ensuring timelines, budgets, and quality goals are met. Collaborate cross-functionally to secure resources, manage priorities, resolve issues, and ensure team alignment. Oversee adherence to design controls and product development processes. Deliver regular status updates and performance assessments to leadership.
Requirements:
Prior experience in medical device development required; laser systems experience a plus
BS in Engineering (MS preferred)
8+ years of project management experience with complex systems
10+ years in technology development (e.g., laser systems, optics-based medical devices)
Proven track record of delivering multi-functional projects on time and within budget
Strong knowledge of design controls and risk management (FDA QSR, ISO 13485, EU MDR, ISO 14971, IEC 60601/60825/62366)
Skilled in project planning, reporting, and communication
Experience in fast-paced, regulated environments
Requirements:
Prior experience in medical device development required; laser systems experience a plus
BS in Engineering (MS preferred)
8+ years of project management experience with complex systems
10+ years in technology development (e.g., laser systems, optics-based medical devices)
Proven track record of delivering multi-functional projects on time and within budget
Strong knowledge of design controls and risk management (FDA QSR, ISO 13485, EU MDR, ISO 14971, IEC 60601/60825/62366)
Skilled in project planning, reporting, and communication
Experience in fast-paced, regulated environments