Job Description
Job Description
Job Title : Sr. Program Manager
Department : Operations
Direct Manager (Title) : VP, Global Operations
Office Location : Miami, US
Job Summary :
The Sr. Program Manager will be accountable to create and track the project timelines, resourcing and project risks & mitigations by leading cross-functional teams in the production of medical devices to consolidate manufacturing operations, ensuring compliance with regulatory requirements, quality standards, and business objectives. This role bridges R&D, operations, quality, clinical, regulatory and supply chain to deliver seamless product launches and scale-up activities.
Essential Duties and Responsibilities
- Lead and implement a company-wide, standard approach for project management
- Create and manage the overall active project portfolio for the company
- Drive Project Success : Assign tasks, responsibilities, and accountability to team members to create and execute project plans in accordance with policies and practices.
- Ability to prioritize tasks and delegate when appropriate.
- Excellent time management skills with a proven ability to meet deadlines.
- Utilize Six Sigma, Lean, and other process improvement methodologies to enhance process performance.
- Work closely with cross functional team members including R&D, Operations, Quality, Regulatory, Sales and Marketing teams to support the transition of new products from development to manufacturing and commercial launch
- Prepare and present updates for ongoing projects, process improvement initiatives and project status to management.
- Lead and participate in product transfer and process improvement projects, ensuring timely and successful completion.
- Manage Cost, Schedule and Performance to meet project objectives.
Requirements (Relevant Education / Languages, Skills)
Bachelor’s degree in Engineering or a related field8+ years of experience in medical device project management, manufacturing, product development, or technology transferProven experience as a Project Manager in the Class III medical device industry.Strong knowledge of manufacturing processes, equipment, and technologies specific to medical devices.Familiarity with FDA regulations, design controls, clinical trails, ISO 13485, and other industry standards.Proficiency in process improvement methodologies (Six Sigma, Lean, etc.).Excellent analytical, problem-solving, and project management skills.Strong communication and interpersonal skills, with the ability to work effectively in a team environment.PMP and / or Sigma Six (Green / Black Belt) Certification preferred.