Manufacturing Engineer

Role Purpose

The Manufacturing Engineer – Single Use Technology is a multi-disciplined role requiring a strong understanding of engineering principles and hands-on experience in product manufacture and design within a medical device or single-use environment.

In this role, you will support onsite manufacturing operations by defining manufacturing and inspection processes, with a particular focus on cleanroom manufacture and assembly of single-use bioprocessing bags and components. You will drive operational efficiency and product quality, support investigations and corrective/preventative actions, and ensure scalable, compliant manufacturing in a GMP-like environment.

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Main Duties

• Define manufacturing and inspection processes necessary for the production of internally manufactured parts.

• Ensure all manufacturing processes and documentation (including CNC cutting programs, welding programs and recipes, tool sheets, work instructions, SOPs, quality plans, and product structures) are compiled, reviewed, and completed to meet relevant deadlines.

• Investigate manufacturing issues or failures and implement effective corrective and preventative actions.

• Collaborate with senior team members to make technical decisions for manufacturing processes currently running or scheduled for production.

• Provide technical support to cleanroom technicians during manufacturing processes and assist with daily technical queries or issues.

• Carry out any additional tasks deemed appropriate for the role of Manufacturing Engineer.

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Key Competencies

• Excellent attention to detail

• Strong communication skills

• Methodical and thorough approach to work

• Effective problem-solving and solution-resolution abilities

• Ability to self-manage and collaborate within cross-functional teams

• Strong technical and analytical skills

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Skills and Experience

• Minimum of 3 years’ experience in a medical device, single-use flexible technology, or component production environment

• Strong understanding of ISO 13485 and cleanroom manufacturing operations

• Proficient in reading and interpreting technical drawings and documentation

• Solid understanding of CAD modelling

• Strong knowledge of plastic film welding processes, testing, and validation

• Experience in single-use component manufacture (desirable)

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Qualifications

• Degree (or equivalent) in a relevant mechanical or biomedical engineering discipline, preferably with a focus on manufacturing engineering