Sr Program Manager

The Sr. Program Manager will have 20+ years’ experience in product development and project management. Familiarity with Class II or Class III medical products would be helpful. An aptitude for detailed project planning with strong team-oriented skills and abilities would be desirable. Person should be self-driven and typically works on projects involving more than one functional area. This includes leading planning, due diligence, and ensuring on schedule implementation of strategic programs within the company product portfolio.

Duties and Responsibilities include, but are not limited to:

• Develops high-level project plans and provides feedback on development strategy, development cost, product cost, project risks and timelines for each project

• Manages and coordinates multiple programs simultaneously

• Manage deliverables from multiple cross functional project teams of internal and external personnel through frequent teleconferences and in-person meetings to ensure resources are brought to bear in a timely fashion to resolve issues and assess opportunities to demonstrate system level integration readiness

• Assess project requirements and manage them to completion; identify personnel resource needs and communicate project status, present proposals and recommendations to mitigate logistics concerns to management

• Have basic domain background to help proactively identify dependencies in the program which can have the schedule impact

• Work closely with Marketing, Quality & Regulatory, Manufacturing and Clinical functional areas to meet project completion timelines

  Knowledge, Skills, Abilities and Requirements:

• BS in EE/BME/ME/CS

• MS/Ph.D./MBA would be an advantage

• 15+ years’ experience in program management, medical device experience will be a plus

• Good understanding of regulated product development

• Proven skills in understanding customer needs for diagnostic medical devices

• Good knowledge of documentation and process needs to meet FDA and CE regulatory requirements

• Experience in managing projects from inception to post-market sustaining

• Self-motivated person with a strong execution ability

• Must possess communication and interpersonal skills to work effectively in a fast-paced environment with minimal management oversight

• Must have strong analytical skills to analyze dependencies in a project and be able to proactively understand and anticipate the critical paths on projects