Project Manager-Senior

About the role

Reporting to the Director of Engineering, the Technical Project Manager will lead technical projects through planning, scheduling, budget management, resource management for change control and stage gate projects in alignment with the department's SOPs in a matrix of cross-functional groups.

Responsibilities

• Lead and deliver projects as a project management expert.
• Lead risk assessment for technical and project-related issues and develop mitigation plans to ensure appropriate mitigations are in place, maintaining schedule and costs.
• Develop and maintain detailed project plans, timelines, budgets, and resource allocations.
• Track and manage project budgets, metrics, and resource utilization.
• Facilitate regular project meetings, track progress, and manage risks and issues.
• Report out progress, issues, and status at regular review meetings.
• Achieve compliance with regulatory, quality, and business requirements.
• Manage multiple concurrent projects and ensure timely progress reporting and escalation of issues impacting delivery.
• Collaborate with Product Development, Quality, Regulatory, Manufacturing, and Supply Chain teams.
• Coordinate with external vendors and contract manufacturers as needed.
• Serve as the primary point of contact for project status and communication.
• Manage engineering change orders, product updates, and obsolescence strategies.
• Support root cause analysis and corrective/preventive actions (CAPA).
• Drive cost reduction, reliability improvements, and design optimizations.
• Oversee the design, validation, and implementation of manufacturing fixtures and tooling.
• Ensure fixtures meet ergonomic, safety, and regulatory standards.
• Support process validation (IQ/OQ/PQ) and documentation.

Requirements

• Education & Experience:
  • Bachelor's degree in Engineering, Biomedical Engineering, Computer Science, Mechanical Engineering, or related field.
  • 3+ years of project management experience in the medical device industry.
  • Experience with sustaining engineering and manufacturing support is a plus.
• Skills & Competencies:
  • Strong knowledge of FDA 21 CFR Parts 820, design controls, ISO 13485, and GMP.
  • Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira).
  • Excellent communication, leadership, and organizational skills.
  • PMP certification or equivalent is a plus.
  • Familiarity with CAD tools and fixture design principles is a plus.