Summary

The Director, Manufacturing oversees supply chain, logistics, in-house production and contract manufacturers to ensure the highest quality products are provided to our customers in support of forecasted demand. This position will have direct reports and reports to the VP, Operations and Quality.

Licensed by the State of California as a Home Medical Device Retail Exemptee (Durable Medical Equipment) after completing 1 year of employment.

Assumes responsibility for overall Durable Medical Equipment (DME) operations and services, as defined in SOP-9001 DME Policy and Procedure Manual, in the absence of the Vice President, Operations and Quality.

Applicants must be currently authorized to work in the United States on a full-time basis. Cala will not sponsor applicants for work visas.

The compensation range for this role is market driven, with a salary range of $185,000 - $210,000. Additionally, we offer a robust benefits package. This offering is aligned with our overall compensation philosophy.

The Opportunity

• Lead and motivate our operations team to consistently achieve business goals and objectives, in full compliance with Cala’s Quality Management System
• Create a culture of trust, continuous improvement, and customer focus
• Train, supervise, and mentor employees to help them perform at their highest ability
• Production:
• Develop a build plan to support forecasted demand; track performance and adjust as needed
• Coordinate with Commercial, Clinical, and Development teams to identify their device needs and incorporate into build plans
• Perform time studies to estimate production capacity and identify ways to improve efficiency
• Coordinate build plan with purchasing to ensure stable stream of inventory with minimal excess
• Supply Chan and Logistics
• Oversee contract manufacturer and supplier performance in collaboration with Quality, with an eye towards supplier risk mitigation
• Purchase materials in support of the build plan, with the goal of zero production downtime due to part shortages
• Ensure orders are fulfilled within agreed to service levels and in compliance with DME requirements
• Manufacturing Engineering:
• Support Development team to transfer new product designs into commercial production (NPI)
• Provide engineering support for manufacturing operators - troubleshoot issues, conduct training, ensure processes are followed and properly documented
• Engage manufacturing operators in identifying ways to improve processes
• Design fixtures and identify equipment to optimize production
• Develop and execute process validations, including IQ/OQ/PQ for fixtures and equipment
• Identify KPIs, set baselines and establish targets (weekly reporting)
• Oversee material tracking, availability, and resource planning
• Collaborate with Therapy Access and Revenue Cycle Management teams to ensure product is shipped in a timely manner
• Represent Manufacturing within cross-functional core team(s) across Cala
• Support and improve the business process centered on the NetSuite platform
• Perform other duties as assigned

Skills and Experience

• BS Degree in Engineering from an accredited institution
• 5-7 years related experience
• Experience using NetSuite to manage production and inventory required
• Lean Manufacturing experience required
• Excellent communicator
• Collects and uses data to identify root cause of issues before considering solutions
• Able to write clear, concise instructions to carry out complex tasks
• Detail oriented with an ability to effectively prioritize work
• Experience working in an FDA regulated environment
• Self-directed, able to work effectively in a start-up environment
• Experience with DME operations highly desired