Manufacturing Process Specialist

5 days ago

Dublin, Dublin City, Ireland beBeeProcess Full time €75,000 - €85,000
About the Role

We are seeking an experienced Senior Process Engineer to support manufacturing in the design, development, and implementation of advanced and high-volume manufacturing processes for medical devices.

This role will play a key part in supporting new product introductions, managing external vendors, and providing expertise related to process development and automation design.

Key Responsibilities
  • Design and optimize robust manufacturing processes to ensure high yield and consistent product quality.
  • Lead process development from concept through to full-scale production on the manufacturing floor.
  • Support large tech transfer projects with external suppliers.
  • Collaborate with R&D teams to transition new devices from development through validation into production.
  • Manage external vendors for the design, build, and integration of new manufacturing equipment.
  • Prepare and maintain process documentation, author and execute validation protocols (IQ/OQ/PQ).
  • Drive continuous improvement initiatives for efficiency, automation, and product quality.
  • Oversee commissioning, scaling, and validation of new technologies.
  • Partner with EHS to conduct risk assessments for new equipment, materials, or processes.
  • Act as a subject matter expert in specific manufacturing technologies and mentor colleagues.
Qualifications
  • Bachelor's degree in Engineering or Science with relevant experience.
  • Minimum 10 years' experience in the medical device manufacturing industry, especially medical device process development and automation.
  • Solid knowledge of medical device regulations.
  • Excellent analytical, problem-solving, and project management skills.
  • Strong communication and interpersonal skills; ability to influence, collaborate, and deliver cross-functionally.
  • Proficiency in MS Office and project management tools.

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