Program Manager

Responsibilities

• Lead and motivate a cross-functional, hybrid agile team to successfully deliver compliance, supply continuity, and quality projects for a blood specimen collection product group.
• Work with Product Owners and SMEs to decompose a project backlog into a prioritized task backlog.
• Optimize value delivered to the organization by planning sprints from the task backlog taking care to plan backward from impact dates and ensuring alignment with organizational goals and regulatory requirements.
• Implement and champion agile project management methodologies to enhance project efficiency and adaptability.
• Foster a collaborative and sprint-oriented project environment, ensuring continuous improvement and responsiveness to changing priorities.
• Ensure proper phase-gate processes are followed for each project as well as drive the completion of all relevant Design History File and Change Control paperwork.

Position Requirements

Education/Experience

• BS degree in Mechanical Engineering, Materials Science Engineering, Biomedical Engineering or a closely related engineering degree is required. An advanced degree in an engineering discipline or MBA is preferred.
• Overall 10+ years of experience is mandatory.
• At least 8 years relevant experience in product development and design; experience in medical devices/products is a plus.
• Minimum of 5 years project management experience.
• Experience in medical device industries required, including experience in FDA or other regulated environments required.
• Exceptional analytical, critical thinking and problem-solving skills. Demonstrated learning agility of new subject matter.
• Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
• Ability to take disparate data points and make sound business decisions and bring clarity to ambiguous situations.
• Demonstrate leadership, learning agility and action orientation when facing uncertainty. Instill confidence through leadership and actions.

Licenses or Certifications

• Program Management Professional Certificate Preferred

Special Skills

• A Six-Sigma design and development background is preferred.
• Has successfully completed design change activities for medical devices.
• Experience developing Class II medical devices.
• Experience utilizing combination of analytical, statistical, computational, and empirical methods to gain deep understanding of design and minimize overall development timelines.

Location: Bengaluru, India

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