Senior Manager, Manufacturing & Operations

About the Role

Ventaris Surgical is seeking a hands-on Senior Manager of Manufacturing & Operations to execute the day-to-day build-out of the company's manufacturing capabilities, reporting to the VP of Operations. This is an execution-focused role for someone who wants to be directly on the floor: running production, solving technical problems in real time, and turning the operational strategy into working reality.

This role suits a builder who thrives on hands-on execution — someone who wants to run the day-to-day of a complex electromechanical Class II medical device manufacturing operation, from early-stage clinical builds through commercial-scale production.

Responsibilities

• Manufacturing Execution
  • Execute day-to-day manufacturing operations, including production scheduling, staffing, and floor-level problem solving
  • Lead manufacturing readiness, production execution, technician leadership, process controls, and transfer-to-production
  • Partner directly with the R&D team on hands-on prototype and early-stage builds
  • Implement and maintain equipment, tooling, and process documentation
  • Directly supervise and develop manufacturing technicians and operators
• Product & Process Development Support
  • Execute design-for-manufacturability (DFM) feedback and support design transfer activities
  • Run process validation activities (IQ/OQ/PQ)
  • Troubleshoot production and technical issues in real time, escalating systemic issues to the VP of Operations
• 6-Scaling Production
  • Execute production plans, capacity plans, and daily/weekly output tracking
  • Support selection, implementation, and day-to-day administration of ERP/MES systems
  • Coordinate demand-planning inputs with the sales team and support inventory planning execution
• Supply Chain Execution
  • Manage day-to-day vendor relationships and purchase orders within the supplier strategy set by the VP of Operations
  • Track component lead times and inventory levels, and support execution of dual-sourcing plans
• Operational Excellence and Quality
  • Ensure day-to-day manufacturing floor operations comply with FDA QMSR (21 CFR Part 820, incorporating ISO 13485:2016) and applicable international requirements
  • Support Quality and Regulatory teams during audits and notified body inspections with documentation and floor walkthroughs
  • Maintain process-level risk management documentation (PFMEA) and support continuous improvement initiatives
  • Manufacturing quality systems support, including: NCR/CAPA support, production records, lot history/DHR completeness, training records, controlled documentation, and cleanroom/controlled-environment discipline

Qualifications

• 6-8+ years of experience in medical device manufacturing/operations, with direct, hands-on floor-level leadership experience
• Experience in an early-stage or scaling medtech environment, ideally having supported a product through FDA clearance
• Strong hands-on technical and mechanical aptitude, particularly with complex electromechanical devices
• Comfortable executing against a strategic plan set by others, rather than defining strategy independently
• Direct supervision of production technicians/operators in an FDA/ISO 13485 manufacturing environment
• Detail-oriented and process-driven, with the ability to work well in ambiguity while staying focused on execution

Preferred: experience with single use, terminally sterile devices

Preferred: ERP/MES implementation, and FDA/ISO audits

Skills

• A true "doer" who wants to be on the floor, not just directing from above
• Takes a strategic plan and turns it into working, repeatable production reality
• Strong communicator who partners well with R&D, Quality, and the VP of Operations
• Comfortable owning tactical, hands-on execution while the VP focuses on strategy, systems selection, and organizational build-out