Having issues with Copilot?Please update to version 1.6.3 by going to Manage Extensions → Update

Program Manager
Posted on 9/22/2023
Billerica, MA, USA
Experience Level
Desired Skills
  • 3+ years experience of Project Management
  • Working knowledge of device regulations, including 21 CFR 820, ISO 9001, ISO 13485, ISO 14971
  • Experience with electronic document management systems and/or risk management software
  • Experience in leading cross-disciplinary product development teams: R&D, Marketing, Quality, Field Service, Operations, etc
  • In-vitro diagnostic (reagents and instrumentation/software) experience desired
  • Able to work independently, with minimal daily guidance
  • Highly organized and detail oriented
  • Proficiency with standard business tools: word processing, presentations, spreadsheets, internet software, manufacturing software, database software
  • Strong work ethic and organizational skills to manage multiple projects under tight deadlines with a collaborative attitude is a must
  • Program leader accountable for overall program outcome; maintaining and expanding ISO 9001 & ISO 13485 QMS initiatives Program responsibilities may extend to leadership of other critical product related initiatives based on portfolio priorities and needs (e.g. process improvement programs)
  • Program Core Team Leader and primary liaison to the Program Governance team
  • Lead Core Team to ensure tight coordination of cross-functional deliverables and providing guidance on conformance to established Quality process improvements and ensuring successful execution of the program. Hold team members accountable for areas of responsibility to the program team and ensure support and focus on objectives
  • Drive concise and clear program updates to Governance Team ensuring delivery of accurate and timely updates, and appropriate escalation and remediation of risks
  • Define and document program scope, constraints and assumptions in detailed integrated program/project plans including schedule and resource needs in accordance with the strategic goals and priorities of the organization
  • Establish and maintain a program risk registry and drive execution against risk mitigation plans as required to achieve program objectives
  • Proactively implement and manage changes to the integrated program/project plans to ensure goals are achieved including customer satisfaction, safety, and quality, in a manner that is consistent with Quanterix company values
  • Ensure program execution to appropriate quality standards of practice consistent with our Quality roadmap and Quality Management System
  • Program Manager responsibilities extend to successfully managing and leading multiple high visibility, time sensitive and complex programs in parallel
Desired Qualifications
  • Minimum of a Bachelors Degree required in a technical field (Biomedical, Software, Electrical, Mechanical Engineering or equivalent), Advanced degree is a plus in Business or equivalent