Job Specification - Operations Lead
Company Overview
An early-stage medical device start-up company focused on the design and development of novel devices.
Position Overview
We are seeking a highly skilled and experienced Operations Lead to join a dynamic team.
The successful candidate will play a key role in overseeing and optimizing manufacturing processes for medical devices.
The Operations Lead oversees manufacturing, supply chain, and product distribution, ensuring compliance with the Quality System.
Reporting to the CEO, this role drives best-in-class medical device manufacturing.
Key Responsibilities
New Product Introduction
Establish new manufacturing lines and/or cleanroom space
Manage validations of processes
Provide design for manufacture input to R&D
Production Management
Financial planning and reporting
Demand planning across functions
Scheduling builds with subcontract manufacturers
Managing training plans and resources
Monitoring efficiency and implementing lean principles
Risk management and production strategy
Stock management and control
Supply Chain Management
Supplier management and capacity planning
Procurement and stock level management
Technical supplier engagement
Cost reduction initiatives
Qualification of additional suppliers
Logistics and Distribution
Manage product shipments
Stock control systems
Storage of finished and quarantined goods
Product shipping to customers and distribution centres
Full traceability systems
Requirements
Bachelor's degree in engineering or related field
10 years' experience in medical device operations
Strong engineering and regulatory knowledge (FDA, ISO *****)
Experience with ISO ***** risk management
Process validation expertise
Strong communication and problem-solving skills
Ability to manage multiple priorities in a fast-paced environment
#J-*****-Ljbffr