Senior Program Manager - LOX

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

We are a medium-sized global leader in bio-medical products, seeking a dynamic and experienced Senior Program Manager to join our PMO team at Caire, reporting to the Head of Global Engineering.

The Senior Program Manager will play an integral role in driving new product development, enhancing manufacturing processes, driving cross-functional teams in the U.S., and managing external global design and manufacturing partners. This role requires deep knowledge of medical device standards and the proven ability to lead large, multi-site, global programs from inception through commercialization.

Essential Functions

• Provide end-to-end program leadership for the redesign of oxygen delivery devices, including stationary and portable oxygen concentrators and liquid oxygen systems.
• Drive cross-functional collaboration between U.S.-based teams (R&D, Regulatory, Quality, Operations) and global design partners and contract manufacturers.
• Develop and maintain detailed global program plans, timelines, and resource allocations aligned with corporate goals.
• Ensure strict compliance with relevant international standards such as IEC 60601, IEC 80601, IEC 62366, ISO/FDIS 18777-1, ISO 21010, ISO 13485, and EU MDR.
• Facilitate cultural understanding and alignment between all global team members, recognizing regional differences in communication, expectations, and decision-making.
• Stakeholder Management: Build and maintain strong relationships with internal stakeholders and external partners.
• Serve as the central point of accountability for scope, schedule, cost, risk, and quality.
• Foster and champion a strong company culture around transparency, predictability, and accountability
• Track and report program status to senior leadership, escalating key risks and mitigation plans as needed. Gather feedback and incorporate it into project planning and execution.
• Manage program documentation, including DHF content, regulatory submissions, and phase reviews
• Lead design reviews and phase gate assessments in collaboration with engineering and business leadership.
• Oversee smooth transition of new product designs or redesigned products into manufacturing scale-up and commercialization phases.
• Analyze existing processes to identify bottlenecks and implement solutions to streamline operations.
• Develop and track key performance indicators (KPIs) to measure the effectiveness of process improvements.
• Facilitate continuous improvement initiatives across the organization.

Competencies/Success Factors

• Mechanical Skills
• Project/ Task Management
• Analytical Skills
• Team Orientation
• Coaching/ Developing OthersProblem-Solving
• Leadership

Supervisory Responsibility

No direct reports, but responsible for cross-functional and partner alignment.

This job operates in a professional office environment with virtual collaboration across time zones. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and audio/visual equipment.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle or feel objects, tools or controls and talk or hear. The employee is occasionally required to stand, walk, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision and the ability to adjust focus.

Travel

Up to 20% international travel, including visits to global CAIRE partner sites.

Required Education and Experience

• 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, especially across teams in multiple locations, worldwide.
• Expert in medical device development lifecycle and design controls.
• Deep familiarity with relevant medical device standards: 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). Certification in Project Management (PMP, PMI-ACP, etc.) is a plus.
• Strong decision-making, stakeholder management, and conflict resolution abilities.
• Excellent written and verbal communication, presentation, and collaboration skills.
• Direct experience managing global, cross-functional teams including remote or offshore design partners.
• Demonstrated success leading complex product development programs across multiple geographies.

Preferred Education and Experience

• Master’s degree in Engineering, Business, or related discipline.
• Familiarity with hazard analysis, FMEA, and risk management per ISO 14971.
• Hands-on experience with test instrumentation, data acquisition, and reliability validation for cryogenic systems.
• Knowledge of DFx, DFMEA, and lean product development.
• Understanding of manufacturing factory metrics and Six Sigma principles.
• Familiarity with liquid oxygen tank design, usability, and manufacturing processes.

Additional Eligibility Qualifications

None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

CAIRE is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.