Senior Project Manager- Medical Device #5451 (Part-time) In MA

• Employee Type Contractor
• Required Degree 4 Year Degree

Description

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects.

Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About The Role

The Senior Project Manager will lead cross-functional teams in transferring equipment used in the production of medical devices to consolidate manufacturing operations, ensuring compliance with regulatory requirements, quality standards, and business objectives. This role bridges R&D, manufacturing, quality, and supply chain to deliver seamless product launches and scale-up activities.

What you’ll do

• Lead end-to-end technology transfer projects, from planning through validation and production release.
  Manage clients’ customer communications
  Develop and manage detailed project plans, timelines, budgets, and risk mitigation strategies.
  Coordinate cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Supply Chain.
  Ensure compliance with FDA, ISO 13485, and other applicable regulatory standards.
  Oversee process validation, equipment qualification, and documentation transfer.
  Drive continuous improvement in transfer processes to ensure timely completion of deliverables and ensure product quality.
  Communicate project status, risks, and milestones to senior leadership and stakeholders.
  Responsible for coordination, implementation, execution, control, and completion of assigned project(s)
  Provide project management support to assigned project(s)
  Responsible for the overall project management specifically focused on ensuring overall client satisfaction and quality of delivery, and performance of the engagement
  Develop resource plans and facilitate resource loading activities
  Develop workflows for project optimization
  Utilize appropriate project management tools and techniques to drive project execution

What you will bring

Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
10+ years of experience in medical device manufacturing, product development, or technology transfer.
Proven track record managing complex, multi-site projects in a regulated environment.
Strong knowledge of design control, process validation, and manufacturing scale-up.
Results-oriented, positive attitude focused on delivering timely, accurate and best in class execution
Ability to draw conclusions and make business recommendations based on cross-functional team input
Exceptional leadership, communication, and problem-solving skills.
PMP certification or equivalent project management training preferred.
Proficiency in MS Office applications including MS Project

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.