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Medical Device Process Specialist

2 months ago

Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time
About the Role

We are seeking a highly skilled Process Development Engineer to join our team at Gyrus Medical Limited. As a key member of our organization, you will play a critical role in the development and implementation of processes that drive our business forward.

Key Responsibilities
  • Process Design and Development: Design, develop, and implement assembly processes, including line set-up/layout, equipment identification and allocation, jigs and fixtures, and data collection and analysis.
  • Process Technology and Innovation: Evaluate new projects in relation to processes and manufacturing, driving continuous improvement and innovation in process development.
  • Validation and Compliance: Develop processes that comply with Good Manufacturing Practice (GMP), process validations, and other quality system documentation requirements.
  • Documentation and Communication: Prepare manufacturing documentation, technical reports, and presentations to ensure smooth transition into manufacturing.
  • Continuous Improvement: Collaborate with other functions to assess process methods, minimize process time and scrap, and maintain and improve customer quality, output, and equipment maintenance.
Requirements
  • Education and Experience: HNC or Degree in Mechanical engineering, Mechatronics, or another related field, with experience in medical manufacturing processes, technologies, and equipment.
  • Skills and Knowledge: Strong analytical skills, proficiency in data analysis, knowledge of regulatory requirements and standards, and ability to communicate and present at all levels.
  • Personal Qualities: Excellent team player, willingness to take the lead and drive process tasks forward, and ability to adapt to changing project requirements.
What We Offer
  • Hybrid Working: Flexible working arrangements to support work-life balance.
  • Bonus Scheme: Performance-based bonuses to recognize and reward outstanding contributions.
  • Generous Pension Scheme: Comprehensive pension scheme to support long-term financial security.
  • Free Life Assurance: Life assurance to provide peace of mind for employees and their families.
  • Private Medical Insurance: Comprehensive medical insurance to support employee health and wellbeing.
  • Annual Leave: 25 days annual leave, plus bank holidays, to support work-life balance.
  • Employee Assistance Programme: Confidential support and guidance to support employee wellbeing.