Job Title: Associate, Project Manager

Supervisor/Manager Title: Senior Director, Program Management

Job Description Summary: Responsible for leading cross-functional teams through the development and launch of heart valves, delivery catheters, and related components, ensuring projects meet regulatory compliance, quality standards, and timelines while managing budgets, risks, and stakeholder expectations within the complex landscape of medical device development and commercialization. Projects may span globally across the organization to address the most critical business needs including Product Development, Operations, Quality and Regulatory.

Job Responsibilities:

• Project Planning & Execution:
  • Develop comprehensive project plans, including scope definition, timelines, milestones, resource allocation, and budget management.
  • Lead cross-functional teams consisting of engineers, clinicians, regulatory specialists, quality assurance personnel, and marketing teams.
  • Manage project schedules, track progress against key performance indicators, and identify potential roadblocks to mitigate risks.
  • Ensure adherence to regulatory requirements (FDA, ISO, etc.) throughout the product development lifecycle.
• Technical Expertise:
  • Understand medical device design principles, functionality, and technical specifications relevant to the project.
  • Collaborate with engineering teams to translate product requirements into technical design documents.
  • Stay updated on emerging technologies and industry trends in medical device development.
• Stakeholder Management:
  • Facilitate communication and collaboration between different departments, including clinical research, manufacturing, sales, and marketing.
  • Present project updates and key decisions to senior management and stakeholders.
  • Manage stakeholder expectations and address concerns effectively.
• Risk Management:
  • Identify and proactively mitigate potential risks associated with the project, including technical, regulatory, and clinical risks.
  • Develop contingency plans to address unforeseen challenges and ensure project continuity.
• Quality Assurance:
  • Ensure compliance with quality management systems (QMS) and standard operating procedures (SOPs) throughout the project.
  • Monitor and address quality issues to maintain product safety and efficacy.