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 13485)
- Experience with ISO 14971 risk management
- Process validation expertise
- Strong communication and problem-solving skills
- Ability to manage multiple priorities in a fast-paced environment.

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