Job Description

As a Manager of large-scale medical product development programs, you will be responsible for leading both internal and external development partners in the design, test, and system integration of medical devices and instruments. Your role will involve planning all program subsystem and project deliverables, and formulating overall project plans with input from senior management and stakeholders. You will be proactive in identifying and assessing areas of risk, escalating issues in a timely manner, and proposing solutions. You will partner with development team members to drive accountability and high quality of project tasks and deliverables, prioritizing team member activities and following up on actions. You will manage program budgets, generate forecasts, and track actuals against forecasts, monitoring progress to plan and implementing corrective actions or contingencies as needed to maintain commitments.

Your ability to communicate effectively will be key, as you provide management with regular project status updates, variances to plan, and identification of corrective actions. You will work closely with functional management to gain resource commitments and resolve issues, and provide input to directors/managers and senior management on team member performance. You will oversee and facilitate compliance to design control and product development processes, ensuring project team activities and decisions are clearly communicated and documented.

Requirements

• BS degree (MS preferred) in an Engineering discipline
• Advanced skills in project management, projects reporting and presentations
• Excellent written and verbal communication skills
• 5+ 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.

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