Operations Manager
This role involves leading and optimizing expanding manufacturing, facilities, and supply chain functions for a medical device company. Key responsibilities include driving efficiency, quality, compliance, and scalability.
Key Responsibilities:
* Plan and manage day-to-day manufacturing activities, both in-house and with contract manufacturing partners (CMOs).
* Lead the setup of assembly lines within class 8 cleanroom environments.
* Build and refine scalable processes, systems, and operational philosophies.
* Develop structures for managing production schedules, inventory systems, and operations projects.
* Collaborate cross-functionally to align with quality and business objectives.
* Foster strong supplier relationships to meet targets across quality, cost, and delivery.
* Drive manufacturing readiness for clinical and commercial supply.
* Work with product teams to ensure robust design transfer and scale-up activities.
Facilities Management:
Oversee maintenance, safety, and compliance of facilities in collaboration with internal teams. Manage facility upgrades to meet evolving operational requirements.
Supply Chain & Procurement:
* Lead the full supply chain strategy, including procurement, logistics, inventory, and supplier management.
* Build a supply planning process to ensure uninterrupted availability of components and finished goods.
* Monitor and optimize supplier performance; identify and qualify alternative sources as needed.
* Develop and track key supply chain performance metrics.
Leadership & Compliance:
* Recruit, train, and mentor operations staff as the team expands.
* Manage cross-functional teams in production, manufacturing, and supply chain.
* Implement and monitor KPIs, dashboards, and performance metrics.
* Ensure full compliance with relevant regulatory frameworks, including ISO 13485, GMP, and FDA 21 CFR Part 820.
* Champion continuous improvement initiatives across operational areas.
Required Skills & Qualifications:
* Operations experience in manufacturing, facilities, or supply chain.
* Strong leadership and management skills.
* Ability to drive efficiency, quality, compliance, and scalability.
* Excellent communication and collaboration skills.
* Proficiency in supply chain management software.
Benefits:
This is a unique opportunity to help shape a high-impact medical technology solution while gaining direct insight into the operations of a scaling start-up.