Hybrid Project Manager at MGC Diagnostics

MGC Diagnostics is seeking a skilled and driven Project Manager to lead the development of cardiorespiratory diagnostic medical devices. 

This role is responsible for cross-functional leadership of product development from concept through global commercialization, managing internal teams across multiple locations and supporting engagement with technical and operational external partners. 

The successful candidate will drive execution within a structured, stage-gate development environment while ensuring compliance with global regulatory and quality standards.

Essential Functions 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Lead full lifecycle project management of new product development (NPD) for Class II FDA-regulated medical devices, from concept through design transfer and commercial launch.
• Develop and maintain integrated project plans, timelines, resource forecasts, risk registers, and budgets aligned to program objectives.
• Ensure compliance with global medical device regulations including FDA (21 CFR Part 820), ISO 13485, ISO 14971, IEC 60601, and other applicable international standards.
• Drive execution of product development through a stage-gate process, ensuring quality system deliverables and DHF completeness.
• Coordinate activities across cross-functional internal teams, including R&D, QA/RA, Operations, Marketing, and Clinical Affairs, located in multiple geographic regions.
• Collaborate with external partners and suppliers, supporting technical and operations leads to manage vendor deliverables and timelines.
• Facilitate formal design reviews, technical documentation review, and risk management activities.
• Prepare and deliver regular program status updates to senior leadership, including project health, milestones, and risk mitigation strategies.
• Support regulatory submission activities (e.g., 510(k), technical file, global registrations) in collaboration with Regulatory Affairs.
• Promote a culture of accountability, continuous improvement, and cross-functional problem-solving.

Competencies/Success Factors 

• Detail Orientation
• Project/ Task Management
• Results Focus/ Output Orientation
• Personal Energy/ Enthusiasm
• Team Orientation
• Interpersonal Communication
• Leadership
• Problem Solving

Supervisory Responsibility

None. 

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones and photocopiers.

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.

• Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.