Program Manager

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screening to the transplant community.

Reporting to the Manager of PMO under the Operations department, this role is responsible for leading teams to deliver project(s) that span across one or more business functions. This role requires an experienced and highly motivated individual with a strong autonomous background in project management, as well as a deep understanding of the medical device industry and regulatory requirements that govern it.

Primary responsibilities will include:

• Lead cross-functional teams to deliver projects on schedule, within budget, and to the satisfaction of internal and external stakeholders.
• Develop and maintain project plans, timelines, and budgets, and track progress against them.
• Lead risk management and mitigation efforts to minimize project risk and ensure on-time delivery.
• Act as the primary point of contact for internal stakeholders, ensuring that all project requirements are met and that customer expectations are exceeded.
• Manage project change control and ensure all changes are properly evaluated and approved.
• Collaborate with cross-functional teams and stakeholders to develop and maintain project deliverables.
• Continuously monitor and improve project performance and implement best practices.
• Ensure compliance with all relevant regulatory requirements, including FDA and ISO regulations.
• Travel overnight(s) as necessary both domestically and internationally to support project goals.
• Other duties as assigned.

Required Qualifications:

• Bachelor’s degree in engineering, science, or related field
• Minimum 5-7 years of experience in project management in the development and release of medical devices
• Strong understanding of FDA and ISO regulations, including full product realization, clinical analysis, and lifecycle management
• Proven track record of successfully leading multiple cross-functional teams in parallel
• Excellent written and verbal communication skills
• Strong leadership skills and the ability to motivate and lead teams
• Proficient in project management tools and software
• PMP or equivalent certification is a plus

Other Requirements:

• This role is an on-site position in the Greater Boston area (Waltham, MA).
• Must be willing to travel domestic and/or internationally approximately 10% of the time

Salary range is $98,000-$127,000 based on experience