NPI Engineer for Medical Devices

16 hours ago

Galway, Galway, Ireland beBeeManufacturing Full time

Job Title: NPI Engineer for Medical Devices

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About the Role:

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We are seeking an experienced NPI engineer to support our manufacturing operations team. The successful candidate will be responsible for executing equipment, process and test method validations.

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Main Responsibilities:

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  • Support the manufacturing process by understanding process risks and identifying mitigations leading to improving yields and process efficiency.">
  • Track and execute New Product Introduction activities ahead of product commercialization.">
  • Work with equipment vendors to identify areas for process improvement.">
  • Create a strong culture of problem-solving using standard tools like DMAIC and 6 sigma.">
  • Develop and follow a process development plan ensuring budget, risk, and timeline have a high level of focus placed on them.">
  • Collaborate with the R&D team to ensure their programs are facilitated in production plans.">
  • Work with R&D on materials, process, and equipment improvement projects.">
  • Ensure line equipment maintenance and calibration is up to date.">
  • Execute IQ/OQs for lab and production equipment.">
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Requirements:

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To be successful in this role, you will need:

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  • A bachelor's degree in Mechanical Engineering, Manufacturing, Chemical Engineering, Biomedical Engineering, or a related field.">
  • At least two years' experience in a manufacturing or process development-related role in a medical device company.">
  • Experience with new equipment introduction (IQ/OQ) and process characterization and validation.">
  • Knowledge of processes like Lyophilisation.">
  • Demonstrated experience with GDP & GMP standards.">
  • An excellent knowledge of engineering materials used in medical device manufacture such as hydrogels, metals, and polymers.">
  • A strong problem-solver with knowledge and experience of DMAIC or other problem-solving tools.">
  • Excellent communication skills – verbal and written.">
  • Ability to work effectively in a team environment.">
  • Comfortable with hands-on and technical work.">
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About Us:

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We are a leading provider of services in the medical device industry.

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Contact Information:

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Please apply through the provided link.

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