Project Manager

Stereotaxis, Inc.; Minneapolis (MN); On-site; USD 95,000 - 120,000; Full time

Job summary

A leading medical technology company based in Minneapolis is seeking a Project Manager to oversee the development of new products from concept to market launch. This role requires a minimum of 10 years of experience in the medical device industry and strong project management skills. The ideal candidate will ensure compliance with FDA and ISO standards while managing multi-disciplinary projects. This is an in-office position, contributing to innovations that enhance patient care.

Qualifications

• Minimum 10 years’ experience in the medical device industry.
• 5+ years of project management experience in the medical device industry.
• Experience with FDA regulations and ISO 13485.

Responsibilities

• Develop and maintain detailed project plans, including timelines.
• Manage product requirements and traceability.
• Lead design review and risk management activities.

Skills

Project management skills

Communication skills

Risk management

Education

Bachelor’s degree in biomedical or mechanical engineering

Job description

Location: Minneapolis, MN 55401 US (Primary)

Job Type: Full-time

Company Description:

Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere. For more information, please visit www.stereotaxis.com.

Position Summary:

The Project Manager will be responsible for overseeing and managing the development of new products from concept to market launch while ensuring that projects are completed on time, within scope, and on budget, while maintaining strict compliance with industry standards.

Essential Responsibilities:

• Develop and maintain detailed project plans, including timelines, milestones, and deliverables.
• Manage product requirements and traceability.
• Lead design review and risk management activities.
• Manage technical partners/ vendors supporting product development activities.
• Ensure all projects comply with FDA, ISO 13485, and other relevant medical device industry regulations and standards.
• Identify potential project risks and develop mitigation strategies. Conduct regular risk assessments and adjust plans as needed to address emerging issues.
• Other assignments as requested.

Qualifications & Skills:

• Bachelor’s degree in biomedical or mechanical engineering.
• Minimum 10 years’ experience in the medical device industry.
• 5+ years of project management experience in the medical device industry.
• Proven track record of managing complex, multi-disciplinary projects from concept to completion, including product development and manufacturing transfers.
• Experience working with FDA regulations, ISO 13485, and other medical device industry standards.
• Must possess good project management skills and initiative in taking on and completing projects.
• Must possess good verbal and written communication skills.
• Legally authorized to work in the United States.

Work Conditions:

This role is an in-office position at Stereotaxis’ Rogers MN facility.