Program Manager - Systems

Qualifications

• Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering or a related technical field; advanced degree preferred.
• At least a minimum of 10 years' experience leading complex medical device development programs, including capital equipment or system-level products, from concept through commercial launch.
• In-depth knowledge of medical device regulatory pathways (FDA, EU MDR, ISO 13485), submission requirements, and quality system regulations.
• Proven ability to lead and influence cross-functional teams at multiple levels of the organization.
• Experience collaborating with engineering, operations, regulatory, quality, and clinical teams throughout all development phases.
• Exceptional communication and stakeholder-management skills.
• Ability to handle ambiguity effectively and oversee multiple large projects at once
• Advanced program planning skills, including WBS, dependency management, critical path analysis, scope control, risk management, and governance reporting.
• Ability to coach peers on stakeholder engagement, communication, scheduling discipline, and program management tools.
• Experience evaluating trade-offs across product features, customer needs, manufacturability, and cost.
• Experience in robotic surgery, software/mechanical/electrical/optical technology based products and design transfer to manufacturing and service organizations.
• PMP certification or formal project management training.
• Familiarity with ALM/PLM systems, Agile methodologies, and project management tools.
• Start-up experience a plus.