Senior Director, Site Operations

JENAVALVE TECHNOLOGY INC•Irvine, CA

1d•$250,000 - $250,000•Onsite

About The Position

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 JenaValve'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.

Requirements

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 workstreams across quality, operations, facilities, and commercial functions without losing discipline or detail.
High integrity and sound judgment; capable of navigating compliance-sensitive decisions with appropriate rigor while maintaining momentum in a fast-moving commercial environment.
Ability to sit, stand, and walk for extended periods throughout the workday, including frequent movement between office, manufacturing, engineering, and production areas.
Ability to access and navigate manufacturing and controlled environments and wear required personal protective equipment (PPE), including cleanroom garments and other safety equipment, as applicable.
Ability to occasionally bend, reach, and maneuver around manufacturing equipment and work areas to observe operations, troubleshoot issues, and conduct operational assessments.
Ability to work at a computer for extended periods and effectively participate in meetings, presentations, and discussions in both office and manufacturing environments.
Ability to occasionally lift or carry materials or equipment weighing up to 25 pounds as needed for site activities.
Ability to perform the essential functions of the position with or without reasonable accommodation.

Responsibilities

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.