Director, Manufacturing

Cala Health•San Francisco, CA

10h•$185,000 - $210,000

About The Position

At Cala, we’re working to free people from the burden of chronic disease. We began by creating the first non-invasive prescription therapy for hand tremor. After years of careful fine-tuning and improvements, we released Cala kIQ — our most sophisticated therapy yet. Our products have empowered thousands of people to get back to their lives with confidence and ease. But we won’t stop there. Our pioneering technology can be applied across neurology, cardiology, and so much more. It’s all part of our mission to help people in their struggle with chronic disease. We’re only just getting started. 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

Requirements

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

Nice To Haves

Experience with DME operations highly desired

Responsibilities

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
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
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
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