Global Oxygen Delivery Program Lead

CAIRE Inc.; Ball Ground (GA); On-site; USD 140,000 - 190,000; Full time

Job summary

CAIRE Inc. is seeking an experienced Senior Program Manager to lead global medical device development programs within the PMO. You will drive cross-functional teams in the U.S.

and with international partners, ensuring on-time delivery of oxygen delivery devices and related systems while maintaining strict regulatory and design controls. You will manage end-to-end program activities, from inception through commercialization, with emphasis on IEC/ISO standards and risk-based product development.

Qualifications

• Bachelor’s degree in Engineering, Biomedical Engineering, or related technical field.
• 10+ years of experience in project or program management roles, with at least 5 years in the medical device industry.
• Proven leadership of large-scale, multi-site global programs in the medical device industry.
• Strong intercultural communication skills across multiple locations.
• Expert in medical device development lifecycle and design controls.
• Deep familiarity with IEC 60601, IEC 80601, IEC 62366, ISO/FDIS 18777-1, ISO 21010, ISO 13485, and EU MDR.
• Proficiency in project and program management methodologies (e.g., Agile, Waterfall, Stage-Gate). PMP/PMI-ACP is a plus.
• Experience managing global, cross-functional teams including remote/offshore partners.

Responsibilities

• Provide end-to-end program leadership for redesign of oxygen delivery devices.
• Drive cross-functional collaboration between U.S. teams and global partners.
• Develop and maintain global program plans, timelines, and resource allocations.
• Ensure compliance with medical device standards and regulatory requirements.
• Lead design reviews and phase gate assessments with engineering leadership.
• Oversee transfer of new designs into manufacturing scale-up and commercialization.
• Track KPIs and report program status to senior leadership.

Skills

Program management

Cross-functional leadership

Regulatory compliance

Stakeholder management

Global teams leadership

Education

Bachelor’s degree in Engineering/Biomedical Engineering or related field

Master’s degree preferred

Job description

CAIRE Inc. is seeking an experienced Senior Program Manager to lead global medical device development programs within the PMO. You will drive cross-functional teams in the U.S.

and with international partners, ensuring on-time delivery of oxygen delivery devices and related systems while maintaining strict regulatory and design controls. You will manage end-to-end program activities, from inception through commercialization, with emphasis on IEC/ISO standards and risk-based product development.