Senior Medical Device Project Manager - NPD & Regulatory

Automatic Data Processing, Inc.; Saint Paul (MN); On-site; USD 117,000 - 125,000; Full time

Job summary

MGC Diagnostics is seeking a skilled Project Manager to lead the development of cardiorespiratory diagnostic medical devices. This role directs cross-functional teams from concept through global commercialization, coordinating internal groups across locations and external partners to ensure on-time, compliant delivery.

You will drive stage-gate development, manage plans, budgets, risks, and regulatory submissions, with focus on FDA 510(k) and quality systems.

Qualifications

• Bachelor's degree in Engineering, Biomedical Sciences, or related field.
• 5+ years in medical device product development with at least 3 years in PM.
• Strong knowledge of medical device design controls and regulatory requirements.
• Proven success leading projects with electromechanical systems, embedded software, firmware.
• Expertise in waterfall development and stage-gate execution.
• Proficient in MS Project, Smartsheet and MS Office Suite.
• Excellent organizational, leadership, communications and stakeholder management.

Responsibilities

• Lead full lifecycle NPD for Class II medical devices from concept to launch.
• Develop and maintain integrated project plans, timelines, resource forecasts, risk registers, and budgets.
• Ensure compliance with FDA, ISO 13485, ISO 14971, IEC 60601 and other standards.
• Drive product development through a stage-gate process with quality deliverables.
• Coordinate cross-functional activities across R&D, QA/RA, Operations and Marketing in multiple regions.
• Collaborate with external partners and suppliers to manage vendor deliverables and timelines.
• Facilitate design reviews, technical documentation review, and risk management.
• Deliver regular program status updates to senior leadership with milestones and risks.
• Track KPIs and prepare status reports for leadership and stakeholders.
• Support regulatory submissions (510(k), technical file, global registrations).
• Promote accountability, continuous improvement and cross-functional problem-solving.

Skills

Project management

Regulatory knowledge

Leadership

Communication

Risk management

Vendor coordination

Cross-functional leadership

Problem solving

Education

Bachelor's degree in Engineering or Biomedical Sciences

Tools

MS Project

Smartsheet

MS Office Suite

Job description

MGC Diagnostics is seeking a skilled Project Manager to lead the development of cardiorespiratory diagnostic medical devices. This role directs cross-functional teams from concept through global commercialization, coordinating internal groups across locations and external partners to ensure on-time, compliant delivery.

You will drive stage-gate development, manage plans, budgets, risks, and regulatory submissions, with focus on FDA 510(k) and quality systems.