Vice President Operations

About the Role

Ventaris Surgical is seeking a Vice President of Operations to design, build, and scale the company’s manufacturing and operational capabilities. This leader will play a critical role in transitioning from development into commercialization, ensuring the organization is prepared to produce high-quality products at scale. This role requires a hands-on operator with deep experience building in-house manufacturing, particularly for complex electromechanical Class II medical devices. The ideal candidate has successfully scaled production from early stage through meaningful volume and understands what it takes to move from prototype to tens of thousands of units.

Responsibilities

• Build Manufacturing from the Ground Up
  • Early integration with R&D team to establish ground-level understanding of prototype device design and construction
  • Design and establish in-house manufacturing capabilities, including facility planning, equipment selection/installation, and process development
  • Develop scalable and traceable manufacturing processes that support clinical builds through commercial production
  • Lead hiring and development of the manufacturing and operations teams
• Product and Process Development
  • Support R&D team with design for manufacturability (DFM) and efficient design transfer to internal and external manufacturing locations
  • Lead process validation activities and manufacturing readiness for clinical builds through product launch
  • Support troubleshooting and resolution of technical and production challenges
• Supply Chain and Vendor Strategy
  • Develop and manage supplier strategy, including critical component dual-sourcing and vendor qualification
  • Balance in-house manufacturing with strategic external partnerships where appropriate
  • Optimization of COGS and ability to hit gross margin targets
• Scale Production
  • Drive the transition from development builds to full-scale production
  • Establish production planning, capacity modeling, and supply chain readiness
  • Lead efforts to scale manufacturing from early stage through growth
  • Selection, installation, and validation of ERP and/or MES systems
  • Develop post-launch demand forecasting with sales team, inventory demand planning, and post-market support systems
• Operational Excellence and Quality
  • Ensure manufacturing processes meet medical device quality and regulatory standards aligned per 21 CFR Part 820 and ISO 13485
  • Partner closely with Quality and Regulatory teams to support compliance, inspections, and notified body audits – aid in development of design controls and risk management files (PFMEA, DFMEA)
  • Implement process controls, continuous improvement initiatives, and cost optimization strategies

Qualifications

• 15+ years of experience in medical device operations and manufacturing, VP of Operations (or equivalent) level position at a venture-backed medical device startup
• Proven experience building in-house manufacturing from early-stage environments
• Demonstrated success scaling production from low volume to high volume

Skills

• Proven VP (or equivalent) Operations leadership experience in a venture-backed med device startup or high-growth environment
• True builder with experience creating operational infrastructure from zero
• Hands-on leader who can operate both strategically and tactically
• Strong problem solver who thrives in fast-paced, ambiguous environments
• Ability to scale teams, processes, and systems as the company grows
• Collaborative partner to R&D, Quality, and Commercial teams