Application Software Project Leader

Job Summary

Quantum Surgical is looking for an Application Software Project LeaderĀ to join a team of creative and energetic engineers who are building the next generation of smart tools for minimally invasive therapies.

The Application Software Project LeaderĀ is directly responsible for the successful delivery of Quantum Surgical product development projects. He/she will handle the planning, coordination and leadership of the software development activities throughout the product development lifecycle. The position includes establishing and driving project schedules, requirements, budgets, reviews, issue escalation, and responsibility for project deliverables following good design control practices.

The candidate should have demonstrated experience with early stage product development and managing complex innovation programs.

Key Responsibilities

  • Lead, plan and coordinate product development activities throughout the lifecycle, from user needs definition to industrialization and validation
  • Create and maintain detailed project plans with work breakdown, deliverables, milestones, resources and responsibilities
  • Lead, motivate and provide day-to-day direction to the project team to ensure on time delivery
  • Organize and lead weekly project meetings to track progress, manage risk and anticipate any impact on the plan
  • Provide timely and accurate information to management
  • Work with Software teams to identify and anticipate the main technical risks, establish the software requirements and deliver quality products on time
  • Work with Risk and Clinical engineers to ensure the proper implementation of risk management
  • Create and maintain an accurate design history file (DHF)
  • Support the RA team in establishing the regulatory filings (CE, 510k, etc.)
  • Follow all applicable regulatory standards and quality procedures

Experiences and Qualifications

  • MS in Engineering or equivalent
  • 8+ years of experience in medical device product development
  • 5+ years of experience as project manager leading software teams
  • Familiar with design controls in a CE/FDA regulated environment
  • Ability to communicate effectively and build relationships with internal/external stakeholders
  • Excellent organizational and communication skills
  • Strong team player

Desired Experience

  • Experience developing software-controlled medical electrical equipment
  • Experience with Agile software development methodology