Quanterix is a company on a mission to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease. In our focused therapeutic areas, our revolutionary technology, Simoa®, is helping researchers advance the science of precision health. Quanterix is changing the way in which the biology of health and disease is studied by giving researchers the ability to closely examine critical biomarkers in neurology, infectious disease, oncology, inflammation, and cardiology. To continue our extraordinary growth, we are hiring a Project Manager, PMO

The Program Manager will manage the cross-functional development and commercialization of immunoassay products, as well and sustaining operations programs to support the organization's strategic imperatives. The position will be responsible for establishing scope, schedule, and resources for programs including performing the necessary tasks to enter a project/product into Design Control and supporting Design Validation and Design Transfer.

What You'll Do:

• Program leader accountable for overall program outcome; typically, commercial success for New Product Development initiatives (from concept to commercial launch and post market review). 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 Design Control procedures 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 complete and robust translation of marketing requirements through to validated product performance.
• 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.
• Assist in development of program/project management best practices, techniques, and disciplines.

What We'll Expect from You:

• 3-5 years of Project Management experience
• 7+ years of experience in the Biotechnology, Medical Device, or Life Science industry
• Technical degree in Science or Engineering fields (preferably in Biochemistry/ Chemistry or SW/ME/EE/biomedical Engineer disciplines); Advanced degrees in sciences or business is preferred.
• Experience in leading cross-disciplinary product development teams: R&D, Marketing, Quality, Field Service, Operations, etc.
• Experience transferring products through phase gated process from R&D through manufacturing preferred. Diagnostic (IVD) experience a plus.
• Strong preference for experience with immunoassay product development programs.
• Experience in 3rd party/vendor relationship management
• Expertise in Microsoft applications including Word, Excel, and PowerPoint; expertise in Project Management software such as Microsoft Project; JIRA, Confluence; working familiarity with requirements management software tools a plus.
• Experience working in ISO 13485 or cGXP environment.
• Very limited travel; <5% of time.
• PMP certification is preferred.

Why You'll Like Working For Us:

Our Technology: Quanterix' technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com.

Our Commitment To Employees: We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day! In addition to competitive compensation and a 401k plan with an employer match, we offer competitive health, dental, and vision benefits for employees and their dependents. We offer a Flexible Spending Account (FSA), Life, Disability, and Accidental Death & Dismemberment Insurances, and Mental Health Care, we offer generous Parental leave, Family Medical Leave, Dependent Care, Military Leave, and Vacation Carryover. All employees are awarded Equity, an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance.

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