Project Manager

Job Summary

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

The Project Manager is directly responsible for the successful delivery of Quantum Surgical product development projects. He/she will handle the planning, coordination and leadership of the R&D 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 requiring input from multiple engineering disciplines.

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 Marketing and Clinical to establish the product technical requirements
  • Work with SW and HW teams to identify and anticipate the main technical risks, establish the SW/HW requirements and deliver quality products on time
  • Work with Risk and Clinical engineers to ensure the proper implementation of risk management & usability engineering activities
  • Create and maintain an accurate design history file (DHF)
  • Support the NPI & manufacturing teams in establishing the device DMR
  • 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/Science or equivalent
  • 8+ years of experience in medical device product development
  • 5+ years of experience as project manager leading cross-functional teams
  • Familiar with design controls in a CE/FDA regulated environment
  • Ability to communicate effectively and build relationships with internal/external stakeholders
  • Excellent organization and communication skills
  • Strong team player

Desired Experience

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