Suru · 6 hours ago
Senior Project Manager
United States
Full-time
Remote
Senior Level, Lead/Staff
$140K/yr - $160K/yr
8+ years expSuru is seeking a Manufacturing Project Manager to lead and coordinate external manufacturing programs for their continuous glucose monitoring system. The role involves managing complex projects, ensuring compliance, and acting as a liaison between internal teams and external contract manufacturing organizations.
Staffing & Recruiting
Hiring Manager
Steven Scott
Responsibilities
Own and manage multiple concurrent manufacturing programs across external CMOs, from planning through execution and sustainment
Develop and maintain integrated project plans, timelines, milestones, and risk registers for sensor manufacturing initiatives
Drive execution against schedules, capacity commitments, and delivery targets in partnership with Supply Chain and CMOs
Identify risks related to supply, process readiness, validation, or scale-up and proactively drive mitigation plans
Act as the primary point of contact between internal teams and external manufacturing partners
Coordinate and facilitate regular CMO meetings, program reviews, and escalation discussions
Hold CMOs accountable to agreed-upon quality, delivery, and performance expectations
Support onboarding of new CMOs, manufacturing transfers, and supplier transitions as needed
Serve as the central interface between Manufacturing, Engineering, Process Development, Quality, Regulatory, and Supply Chain
Translate technical and operational requirements into clear project plans and execution expectations for CMOs
Ensure internal stakeholders are aligned on priorities, timelines, and tradeoffs
Provide informed oversight of wet chemistry–based manufacturing processes , including solution preparation, chemical processing, coatings, and enzyme-related steps used in sensor production
Coordinate issue resolution related to yield variability, process drift, or material performance by engaging the appropriate technical owners
Ensure process changes, deviations, and investigations are tracked, reviewed, and resolved through proper channels
Manage project execution related to engineering changes (ECR/ECOs), process updates, and documentation changes
Coordinate validation activities (IQ/OQ/PQ) at CMOs from a project management perspective
Support audits, inspections, and regulatory activities involving external manufacturing partners
Ensure manufacturing programs remain compliant with ISO 13485 and cGMP expectations
Provide clear, concise status updates to leadership on project progress, risks, and mitigation actions
Escalate issues appropriately and drive timely decision-making across teams
Maintain documentation related to project plans, timelines, and supplier performance
Qualification
Required
Bachelor's degree in Engineering, Supply Chain, Operations, or related technical discipline
8–12+ years of experience in medical device manufacturing, operations, or manufacturing program management
Demonstrated experience managing large, complex manufacturing projects involving external CMOs
Strong working knowledge of wet chemistry–based manufacturing environments (hands-on execution not required)
Proven ability to manage multiple projects simultaneously across cross-functional teams
Experience working in ISO 13485–regulated environments
Excellent communication, organization, and stakeholder management skills
Preferred
Experience supporting sensor, biosensor, diagnostic, or glucose monitoring products
Exposure to manufacturing scale-up, supplier transfers, or capacity expansion initiatives
Familiarity with process validation concepts (IQ/OQ/PQ)
PMP or formal project management training
Experience partnering closely with Supply Chain, Quality, and Regulatory teams
Company
Suru
Suru is a specialized recruiting firm focused on delivering top-tier talent for direct hire and temporary placements across a wide range of industries.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase