Senior Program Manager

InspireMD • Miami, FL

1d

About The Position

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.

Requirements

• 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.

Nice To Haves

• PMP and/or Sigma Six (Green/Black Belt) Certification preferred.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees