Manufacturing Process Leader

3 days ago

Galway, Galway, Ireland beBeeManufacturing Full time €90,000 - €120,000

Lead Manufacturing Process Developer

This is an opportunity to join a rapidly scaling organization as a Lead Manufacturing Process Developer. In this role, you will be responsible for leading the development and implementation of manufacturing processes for our innovative medical devices.

The ideal candidate will have a strong background in engineering and at least 6 years of experience in a manufacturing environment, with a proven track record of process optimization and leadership. You will be responsible for collaborating with R&D teams to optimize product designs for manufacturability and assembly, establishing and validating new assembly lines, and driving root cause investigations and process improvements.

We are looking for a creative and resourceful problem solver who is passionate about innovation and has excellent communication skills. As a key member of our team, you will have the opportunity to shape the growth trajectory of our company and contribute to the development of life-changing technologies that make a real difference to patients.

  • Key Responsibilities:
  • Collaborate with R&D on optimizing product designs for manufacturability (DFM) and assembly (DFA)
  • Establish and validate a new assembly line within a Class 8 cleanroom, including jig and fixture design
  • Lead equipment and process validation for device assembly
  • Support builds for R&D testing, product verification, validation, clinical trials, and commercial launch
  • Develop robust work instructions, test methods, and process controls
  • Drive root cause investigations and resolve process non-conformances
  • Manage timelines for manufacturing projects and coordinate with external suppliers
  • Continuously identify and implement manufacturing process improvements
  • Utilize CAD tools and in-house prototyping equipment to design and refine fixtures
  • Ensure delivery of projects on time, on cost, and to quality standards

Requirements:

  • Degree in Engineering or a related technical discipline
  • At least 6 years of relevant experience in a manufacturing environment, with at least 3 years in the medical device industry
  • Proven expertise in:
  • ISO13485 or equivalent quality management systems
  • Cleanroom assembly and polymer processing
  • Process and equipment validation
  • Root cause investigations and process optimization
  • Managing external suppliers

Additional Advantages:

  • Advanced qualification (Masters or Diploma) in a technical field
  • Experience with PCBs and/or electromechanical components
  • Cleanroom design and assembly line configuration
  • Previous start-up or SME experience
  • Prototyping experience (3D printing, vacuum forming, heat sealing)
  • Supplier process validation (e.g., injection moulding)
  • Leadership in line installations, transfers, or new process development
  • Familiarity with Lean manufacturing tools and methods

Benefits:

  • Comprehensive training and continuous personal and professional development
  • Competitive salary and strong benefits package
  • Flexible working hours and generous vacation policy

What We Offer:

A dynamic and innovative work environment where you can grow your career and contribute to the development of life-changing technologies.

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