Senior Program Manager

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 trials, 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.