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 field
· 8+ years of experience in medical device project management, manufacturing, product development, or technology transfer
· Proven 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.