Reports to
Head of Global PMO
JOB DESCRIPTION
We are a medium-sized global leader in bio-medical products, seeking a skilled and detail-oriented Project Manager to join our dynamic PMO team at Caire, reporting to the Head of Global PMO. The Project Manager will be responsible for overseeing various projects, including new product development, manufacturing, quality and regulatory compliance, change control, and process improvement initiatives. The ideal candidate will thrive in a fast-paced environment and demonstrate adaptability to changing priorities.
Essential Functions
- Project Management: Plan, execute, and monitor projects from initiation to completion, ensuring alignment with company objectives and timelines. Develop project plans, schedules, budgets, and resource allocation strategies. Facilitate cross-functional team meetings to ensure effective communication and collaboration.
- Cross functional Collaboration: Act as a liaison between various departments to foster collaboration and communication. Assist with PDP phase reviews and program reviews.
- Risk Management: Identify potential engineering-related risks and develop effective mitigation strategies to address challenges throughout the product development lifecycle.
- Stakeholder Communication: Facilitate regular updates and communication with stakeholders regarding engineering progress, risks, and resource needs, ensuring transparency and alignment.
- Change Control: Manage change control processes for product modifications, ensuring all changes are documented and communicated effectively. Assess the impact of proposed changes on project timelines and deliverables.
- Process Improvement: Drive continuous improvement initiatives within the engineering function, optimizing workflows and enhancing project efficiency. Improve, recommend, and implement program and project management tools for PMO
- Documentation: Ensure all project documentation is accurate, comprehensive, and compliant with regulatory standards, supporting smooth audits and inspections.
- Other: Support all Company initiatives as identified by management and in support of Quality Management Systems (regulatory requirements. 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.
- Knowledge of medical device development processes, regulatory requirements (e.g., FDA, ISO), and quality management systems is plus
- 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.
- 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 3 years of experience in program management or project management, medical device or related industry preferred
- Proven experience leading/coordinating cross functional teams and deliverables in a cross-functional environment.
- Knowledge of medical device development processes, Medical Device design control processes and associated ISO standards compliance (60601, 13485, etc.) is a plus
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 10%, 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.
