Medical Device jobs in United States

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EVEREC

bedfordshire, United Kingdom

Other

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4

10.06.2025

25.07.2025

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Manufacturing Operations Manager - Medical Device - Bedfordshire - £70k

Location: Dunstable (On-site, 5 days/week)

Sector: Medical Devices / Cleanroom Manufacturing

Job Type: Full-time, Permanent

Reports To: Managing Director

Team Size: 5–10

Company Overview

This is a rare opportunity to join a fast-growing UK medical device manufacturer specialising in cleanroom-produced consumables for healthcare and clinical environments. With over 50 employees and a reputation for precision, compliance, and responsiveness, the company plays a critical role in supplying cleanroom-grade components and devices to the NHS and wider healthcare industry.

The business has grown steadily over the last decade and is now seeking an experienced Manufacturing Operations Manager to lead the production function, drive operational excellence, and contribute directly to the company’s senior leadership strategy.

Role Overview

As Manufacturing Operations Manager, you will lead the day-to-day operations of the production and cleanroom manufacturing facility, overseeing planning, output, process control, and team leadership. You’ll play a key role in ensuring compliance with ISO 13485 standards, enhancing quality systems, and supporting the scale-up of manufacturing to meet growing customer demand.

You will report directly to the Managing Director and work as a core member of the Senior Management Team, contributing to strategic planning and continuous improvement initiatives across the business.

Key Responsibilities

• Lead all aspects of cleanroom-based manufacturing operations, including planning, scheduling, capacity, and output.
• Ensure consistent compliance with ISO 13485, quality management systems, and regulatory best practices for medical device production.
• Manage and develop a cross-functional production team (5–10 people) including team leaders, operators, and support roles.
• Oversee manufacturing processes, process control, and cost-effective production across multiple product lines.
• Work closely with the Quality, Supply Chain, and R&D teams to ensure alignment across departments.
• Monitor KPIs for output, quality, scrap, downtime, and productivity—implementing continuous improvement where required.
• Support audits, inspections, and documentation as required by external regulators and customers.
• Contribute to business strategy as part of the Senior Management Team, offering insight on operational priorities and future growth plans.

Ideal Experience & Skills

• Significant experience in medical device manufacturing and operations, ideally in a leadership role.
• Strong working knowledge of ISO 13485 and cleanroom production requirements.
• Proven success in leading teams and scaling manufacturing operations within a regulated industry.
• Hands-on understanding of production planning, process optimisation, and lean manufacturing principles.
• Clear, confident communicator with a collaborative and proactive leadership style.
• Comfortable working in a medium-sized company where flexibility, initiative, and ownership are highly valued.
• Technical or engineering qualification in manufacturing, production, or a related field.
• Experience in cleanroom consumables, sterile packaging, or single-use medical device manufacturing.
• Exposure to product lifecycle management and working closely with quality assurance and regulatory affairs.