Senior Director, Site Operations

• Location:
  
  Irvine, CA 92618
• Position Type:
  Full Time
• Education Level: 4 Year Degree
• Salary Range: $ - $ Salary
• Job Title:
  
  Senior Director, Site Operations

• Role Level: People Manager
• Supervisor/Manager
  
  Title:
  
  Vice President, Global Operations
• Job Location & Environment:
  Irvine, CA - Corporate

The Senior Director, Site Operations leads the site's production organization, encompassing DS (delivery system/catheter) and valve production, and manufacturing/process engineering. This role owns operational performance across these functions, including output, yield, throughput, cost, and workforce readiness, and brings deep, hands on production and process engineering expertise to drive execution. Facilities and EHS may be incorporated into this role's scope as the site organization evolves.

The Senior Director partners closely with Quality, HR, and other site functions to ensure production activities meet applicable regulatory and quality standards, including U.S. FDA quality and manufacturing standards and the international quality standards underpinning Jena Valve's manufacturing practices. This role reports to the Vice President, Global Operations, and serves as a key operating partner in translating site and corporate priorities into production-level execution.

• Own manufacturing planning and execution across DS and valve production and manufacturing/process engineering, including scheduling, staffing, throughput, yield, and cost performance against targets.
• Apply hands on process and manufacturing engineering expertise to troubleshoot production issues, drive process improvements, and reduce variability and waste.
• Lead capacity planning and production ramp activities in coordination with VP, Global Operations, Supply Chain and cross-functional partners in Quality, Regulatory, and R&D/Engineering.

• Champion a safety-first culture within the production organization, reinforcing that personnel safety and product quality are inseparable priorities.
• Partner with the EHS function to implement safety programs and ensure production activities meet applicable health and safety regulations.

• Partner with Quality leadership to ensure production processes support the Quality Management System and audit readiness.
• Ensure all production and engineering personnel are trained to applicable manufacturing and regulatory standards, with documented competency appropriate to role.
• Escalate quality issues promptly and drive corrective actions within the production organization.

• Lead and develop the production and engineering management team and workforce, including workforce planning, headcount forecasting, and succession and bench strength development.
• Partner with HR on organizational design, performance management, accountability, and culture initiatives for the production and engineering teams.
• Establish clear communication cadences within the organization and with the VP, Operations, to ensure priorities and performance are understood at every level.

• Own a KPI framework for DS and valve production and engineering covering safety, quality, delivery, and cost; use performance data to drive targeted improvement actions.
• Design and build reporting and data collection processes that provide real-time visibility into production performance; support regular operating reviews with the VP, Operations.
• Drive structured problem-solving and a culture of accountability within the organization.

• Serve as the primary point of contact for Quality, Regulatory, and R&D/Engineering on matters affecting DS and valve production execution.
• Partner with Facilities on infrastructure needs supporting production.
• Support the VP, Operations, in translating broader operational and growth strategy into production-level plans and priorities.
• Provide input on production-related capital needs and operating budget as part of the broader Operations budget owned by the VP, Operations.

• Working knowledge of manufacturing operations fundamentals, including process validation, CAPA, change control, capacity planning, and lean/continuous improvement methodologies.
• Able to analyze complex operational, financial, and regulatory data and translate findings into clear decisions and communications for diverse audiences.
• Strong project and program management skills; able to drive concurrent work streams across quality, operations, facilities, and…