Medical Device Project Manager – NPD & Regulatory

MGC Diagnostics; Saint Paul (MN); On-site; USD 120,000 - 160,000; Full time

Job summary

MGC Diagnostics is seeking a Project Manager to lead the development of cardiorespiratory diagnostic medical devices. The role oversees cross-functional teams across locations and partners with external suppliers to drive stage-gate product development and global commercialization.

The successful candidate will manage design transfers, regulatory submissions, and quality system deliverables while ensuring compliance with FDA and international standards.

Qualifications

• Bachelor's degree in Engineering, Biomedical Sciences, or a related technical field.
• Minimum of 5 years of experience in medical device product development with at least 3 years in a dedicated project or program management role.
• Strong understanding of medical device design controls, regulatory requirements, and product development life cycle in a highly regulated environment.
• Proven success leading projects involving electromechanical systems, embedded software, and firmware.
• Expertise in waterfall development methodologies and stage-gate execution.
• Proficient in project management tools (e.g., MS Project, Smartsheet) and MS Office Suite.
• Exceptional organizational, leadership, communication, and stakeholder management skills.

Responsibilities

• 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.
• Coordinate activities across cross-functional internal teams, including R&D, QA/RA, Operations, and Marketing, 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.
• Track departmental and project performance through established KPIs, and prepare regular status reports for leadership and key stakeholders.
• 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.

Skills

Project management

Cross-functional leadership

Regulatory compliance

Stakeholder management

Leadership

Communication

Risk management

Education

Bachelor's degree in Engineering or Biomedical Sciences

Tools

MS Project

Smartsheet

MS Office

Job description

MGC Diagnostics is seeking a Project Manager to lead the development of cardiorespiratory diagnostic medical devices. The role oversees cross-functional teams across locations and partners with external suppliers to drive stage-gate product development and global commercialization.

The successful candidate will manage design transfers, regulatory submissions, and quality system deliverables while ensuring compliance with FDA and international standards.