Project Manager

PROJECT MANAGER to Serve the Medical Device Industry

MANIFEST Technology is seeking a high-energy Project Manager to join our client’s newly formed PMO team in Lowell, MA, focusing on complex medical device development and manufacturing transfers within the thin-film industry. In this "sandbox" environment, you will have the unique opportunity to help build foundational PMO processes while leading high-impact Class II and III device projects from inception to completion. Acting as the primary liaison for external customers, you will own project timelines, budgets, and risk mitigation strategies, ensuring all activities comply with ISO 13485 standards and Design Control requirements. This role is ideal for a proactive leader with a BS in a STEM discipline , at least five years of medical device experience, and a desire to drive meaningful change in a fast-paced, innovative manufacturing setting.

Position type: Direct hire; US Citizen or Green Card Holder; No C2C

Duration: Permanent hire

Location: Onsite in Lowell, MA

Pay Range : $100k-120k Salary / No C2C

RESPONSIBILITIES

• Manages and coordinates development and manufacturing transfer of complex components.
• 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.
• 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, in collaboration with internal management, to meet program goals and milestones.
• Setup project profile in project management/time tracking systems (Fastrack/M2M setup are current systems).
• Manages project invoicing and create purchase orders for project expenses.

REQUIREMENTS

• Minimum BS in a STEM discipline with at least 5 years of experience within the medical device industry.
• Minimum 2 years of experience in project / program management in an ISO 13485 environment.
• Must possess strong understanding and working knowledge of ISO 13485 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.

GOOD TO HAVE

• PMP Certification
• Experience in thin-film industry

NEXT STEPS

• Qualified candidates should APPLY NOW for immediate consideration!
• Please send your resume to ***email_hidden*** and then text/call David Slaymaker at 507 250 4420.