Sr. Project Manager

Cirtec Medical; Enfield; On-site; USD 115,000 - 125,000; Full time

Job summary

An established industry player in medical devices is seeking a Sr. Project Manager to lead the development and manufacturing transfer of complex components. This role involves managing project plans, coordinating across functional groups, and ensuring compliance with quality standards. Ideal candidates will possess strong project management skills, a background in medical device development, and a commitment to innovation and collaboration. Join a team that values growth and is dedicated to delivering high-quality solutions in the medical field.

Benefits

Healthcare and well-being programs

Paid Time Off

401(k) retirement savings with company match

Training and career development

Qualifications

• 5+ years of experience in project/program management of medical device development.
• Strong understanding of ISO 13485 and FDA 21CFR820 based Quality Systems.

Responsibilities

• Manage and coordinate development and manufacturing transfer of complex components.
• Track project health in terms of schedule, budget, and technical risks.

Skills

Project Management

ISO 13485

FDA 21CFR820

Communication Skills

MS Project

Technical Drawing Interpretation

Risk Management

Education

Bachelor's degree in business, engineering, IT, or related field

PMP certification

Tools

MS Office

MS Project

Job description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Sr. Project Manager position is primarily responsible for managing and coordinating development and manufacturing transfer of complex components and finished medical devices.

Key Responsibilities:

• Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.


• Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute project activities based on well-defined prioritization.


• Coordinates activities across different functional groups to ensure successful completion of project goals and milestones.


• Tracks project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders


• Proactively anticipates project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions


• Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements


• Supports project team in establishing and maintaining product requirements and test plans


• Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.


• Manages internal resource allocation to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.


• Reliable, consistent, and punctual attendance is an essential function of the job


• Oversees complex or multiple projects, ensuring alignment with business goals. Manage higher-risk initiatives, mentor junior project managers, and collaborate with senior leadership to optimize processes, budgets, and resources.

This is not a remote position.

Must Have:

• Bachelor's degree in business, engineering, IT, or related field.
  
  PMP certification preferred.


• Minimum 5 years of experience in project / program management of medical device development


• Experience with metals processing and Nitinol-based devices preferred but not required


• Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control


• Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents


• Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders


• Must have proficiency in MS Project and other MS Office software


• Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral


• Willingness to travel, if required

Salary Range: $115-125K Dependent upon experience

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.