Senior Manufacturing Engineer

4 weeks ago


Bedford, Bedford, United Kingdom Werfen Full time

Job Summary

This role requires a combination of technical leadership and project management skills to support a complex range of manufacturing engineering activities. As a Senior Manufacturing Engineer, one will apply advanced knowledge of engineering principles and analyses to solve multifaceted issues related to product design and manufacturing processes. As a Project Manager, one will plan and manage multi-functional product improvement efforts, product transfer projects, and continuous improvement initiatives.

Key Responsibilities

  • Provide technical leadership to cross-functional project teams and ensure design requirements are met and comply with applicable standards.
  • Coordinate technical resources to identify the root cause of project issues and develop and manage a plan to fix, test, and implement an appropriate solution.
  • Ensure project risks are identified and addressed within the project plan and develop risk mitigation plans.
  • Work as a lead project team member to complete all activities needed to conclude projects per plans.
  • Develop and implement process controls for product transfer to manufacturing or to new manufacturing sites.
  • Conduct regular project team status meetings and reviews and oversee validation project teams.
  • Write, review, and approve validations and technical reports for new products, processes, and equipment.
  • Ensure all projects and processes follow FDA, GMP, QSR, and ISO standards.
  • Identify and implement opportunities for continuous improvement.

Requirements

  • Bachelor's degree in engineering; advanced degree a plus.
  • Eight years previous manufacturing engineering experience preferred.
  • Previous experience within a regulated medical device or pharmaceutical environment.
  • Requires full and comprehensive knowledge of the complete product lifecycle.
  • Experience in the development and release of at least one successful product launch of a medical instrumentation product is desirable.

Skills and Capabilities

  • Six sigma green belt or black belt methodology a plus.
  • Extensive knowledge and experience in process and product manufacturing.
  • Experience in creating and understanding engineering drawings, schematics, specifications, tolerancing, and bills of materials.
  • In-depth experience with automation development to suggest proper design improvements.
  • Expertise in writing and performing validations in a regulated environment.
  • Knowledge of statistical sampling and analysis.
  • Understanding of FDA, GMP, ISO standards, and OSHA regulations.
  • Excellent written and verbal communication skills.
  • Excellent equipment failures troubleshooting skills.
  • Working knowledge of MS Office and statistical software.

Travel Requirements

Approximately 20% international mobility required.



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