Program Manager - Medical Device

Job Function:

• Responsible for managing large-scale, highly complex, multi-faceted new medical product development programs, involving internal and external development partners.
• Provides technical leadership in design, test and system integration of medical devices and instruments.
• Plans of all program subsystem and project deliverables.
• Formulates and gains approval for overall project plans in consultation with senior management and stakeholders.
• Proactively identify and assess areas of risk, escalate issues in a timely manner and proactively propose solutions.
• Partners with development team members to drive accountability and high quality of project tasks and deliverables. Continuous prioritization of team member activities and follow up on actions.
• Manages program budgets, generates forecasts, and tracks actuals against forecasts.
• Monitors progress to plan and implements corrective actions or contingencies as needed to maintain commitments.
• Provides management with regular project status, variances to plan, and identification of corrective actions.
• Works closely with functional management to gain resource commitments and resolve issues.
• Provides input to directors/managers and senior management on team member performance. Effectively manages performance issues and conflicts.
• Oversees and facilitates compliance to design control and product development processes.
• Ensures project team activities and decisions are clearly communicated and documented.

Requirements:

• Prior Med Device experience a must.
• Laser experience a plus.
• BS degree (MS preferred) in an Engineering discipline.
• Advanced skills in project management, projects reporting and presentations.
• Excellent written and verbal communication skills.
• 8 years project management experience of complex laser-based systems.
• 10 years technology development experience in one of the following areas: laser systems, electro-opto-mechanical systems, optics-based medical devices.
• Track record of executing complex multi-functional project on time and within budget.
• Ability to manage multiple projects in a fast-paced development environment.
• Proven experience working within controlled product development process.
• Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred.