Reports to
Head of Global PMO
JOB DESCRIPTION
We are a medium-sized global leader in bio-medical products, seeking a dynamic and experienced Program Manager to join our PMO team at Caire, reporting to the Head of Global PMO. The Program Manager will play an integral role in driving new product development, enhancing manufacturing processes, regulatory compliance and/or enabling corporate initiatives to support our mission of delivering innovative respiratory solutions.
Essential Functions
- Planning and Execution: Lead cross-functional teams in the development and launch of new oxygen concentrator products. Collaborate with R&D, marketing, and regulatory teams to define product requirements, timelines, and budgets. Monitor project milestones, deliverables, and ensure alignment with strategic goals.
- Manufacturing Oversight: Work closely with manufacturing teams to identify opportunities for process optimization and efficiency improvements. Implement best practices and lean methodologies to enhance production capabilities and reduce costs. Coordinate the scale-up of new products from prototype to full-scale manufacturing.
- Process Improvement: 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.
- Regulatory Compliance: Ensure that all products and processes comply with relevant regulatory standards (e.g., FDA, ISO). Work with the regulatory affairs team to prepare and submit necessary documentation for product approvals. Stay updated on regulatory changes and industry standards to ensure ongoing compliance.
- Corporate Enablement: Support corporate initiatives related to organizational operational excellence. Act as a liaison between various departments to foster collaboration and communication.
- Stakeholder Management: Build and maintain strong relationships with internal stakeholders and external partners. Present project updates and status reports to senior management and stakeholders. Gather feedback and incorporate it into project planning and execution.
- Project Collaboration: Work alongside the Project Program Manager and cross-functional teams—including R&D, Quality Assurance, Regulatory Affairs, Marketing, and Manufacturing—to develop and maintain project timelines, budgets, and resource allocation. Assist with PDP phase reviews and program reviews.
- Technical Leadership: Provide technical direction and support to engineering teams, facilitating the execution of design and development activities in alignment with industry standards and best practices.
- Risk Management: Identify potential project risks and develop effective mitigation strategies to address challenges throughout the product development lifecycle.
- Documentation: Ensure all engineering documentation is accurate, comprehensive, and compliant with regulatory standards, supporting smooth audits and inspections.
- Foster and champion a strong company culture around transparency, predictability, and accountability
Competencies
- Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across diverse teams.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Strong stakeholder facing skills including being comfortable presenting to large audiences.
- Proficiency in project management tools and methodologies (e.g., Agile, Waterfall). Certification in Project Management (PMP, PMI-ACP, etc.) is a plus.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- Experience managing complex medical device development program and regulatory filings.
- Fluent in Microsoft Office products including Word, PowerPoint, Excel, and Outlook.
Experience Required
- Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field); Master’s degree preferred.
- Minimum of 10 years of experience in program management or project management with 5 years in the medical device or related industry.
- Proven experience leading teams and managing complex engineering deliverables in a cross-functional environment.
- Strong knowledge of medical device development processes, Medical Device design control processes and associated ISO standards compliance (60601, 13485, etc.).
- Awareness and understanding of Company quality standards, capital equipment, procurement, FMEA, APQP, ISO 9001 knowledge and experience preferred.
- Experience with Project Management methodologies such as Visual Project management and tools.
Supervisory Responsibility
No
Work Environment
This job operates in a professional office environment. 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
- Ability to travel up to approximately 20%, including internationally.
Required Education and Experience
- Bachelor’s degree in Engineering or a related technical discipline.
Preferred Education and Experience
- MS or Ph.D. degree in Engineering or a related technical discipline.
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.
