Manufacturing NPI (New Product Introduction) Engineer
An exciting opportunity has arisen for a Manufacturing NPI Engineer to support operations as products transition from pilot production to commercial launch.

Responsibilities

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  Execute equipment, process, and test method validations.
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  Support manufacturing processes, identify risks, and implement mitigations to improve yield and efficiency.
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  Track and drive New Product Introduction activities ahead of commercialisation.
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  Collaborate with equipment vendors to identify and deliver process improvements.
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  Foster a strong problem-solving culture using DMAIC, Six Sigma, and other standard methodologies.
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  Develop and manage process development plans with a focus on budget, risk, and timelines.
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  Partner with R&D to align production with development programs, materials, processes, and equipment improvement projects.
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  Create and maintain master validation plans for line equipment.
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  Ensure equipment maintenance and calibration are completed on schedule.
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  Execute IQ/OQs for lab and production equipment.
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  Apply project management methodologies to communicate and track activities.

Background & Qualifications

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  Bachelor's degree in Mechanical, Manufacturing, Chemical, Biomedical Engineering, or related discipline.
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  Minimum 2 years' experience in a manufacturing or process development role within the medical device sector.
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  Hands-on experience with new equipment introduction (IQ/OQ), process characterisation, and validation.
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  Knowledge of test method validation and processes such as lyophilisation.
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  Strong understanding of GDP & GMP standards.
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  Excellent knowledge of engineering materials used in medical device manufacture (hydrogels, metals, polymers).
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  Skilled problem solver with experience in DMAIC or similar tools.
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  Highly organised, innovative, and able to work independently or as part of a team.
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  Strong communication skills (verbal & written).
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  Comfortable with hands-on technical work.

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