Senior Manufacturing Engineer

2 months ago

Bedford, Bedford, United Kingdom Werfen Full time
Job Summary

This role requires a combination of technical expertise and leadership skills to support complex manufacturing engineering activities and manage multi-functional product improvement efforts.

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 and resolve project issues, develop and manage plans to fix, test, and implement solutions.
  • Ensure project risks are identified and addressed within the project plan, develop risk mitigation plans.
  • Work as a lead project team member to complete all activities needed to conclude projects per plans, responsible for project planning and scheduling.
  • Develop and implement process controls for product transfer to manufacturing or to new manufacturing sites.
  • Conduct regular project team status meetings and reviews, oversee validation project teams, prepare agendas, issue meeting minutes, and participate in development of quality plans.
  • Write, review, and approve validations, Standard Operating Procedures (SOP), technical reports, and final reports for new products, processes, and equipment.
  • Ensure all projects/processes are following FDA, Good Manufacturing Practices (GMP), Quality System Requirement (QSR), ISO-: and other applicable requirements.
  • Identify and implement opportunities for continuous improvement.
  • Communicate project information to both the project team and executive management.
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, including all aspects of product development from conception to manufacturing introduction.
  • Experience in the development and release of at least one successful product launch of a medical instrumentation product is desirable.
  • Product development experience, including three years in successful technical leadership, project coordination, or project management are required.
Preferred Skills and Capabilities
  • Six sigma green belt or black belt methodology a plus.
  • Extensive knowledge/experience in process and product manufacturing.
  • Experience in creating and understanding engineering drawings, schematics, specifications, tolerancing, and bills of materials (BOMs).
  • In-Depth experience with automation development to be able to suggest proper design improvements.
  • Expertise in writing and performing validations in a regulated environment.
  • Knowledge of statistical sampling and analysis.
  • Understanding of Food and Drug Administration (FDA), Good Manufacturing Practices (GMP), ISO Standards, and Occupational Safety and Health Administration (OSHA) regulations; previous experience participating in regulatory audits preferred.
  • Excellent written and verbal communication skills.
  • Excellent equipment failures troubleshooting skills are required.
  • Working knowledge of MS Office; knowledge of statistical software and large enterprise resource planning (ERP) system preferred.
  • Excellent organizational and time management skills; attention to detail.
Travel Requirements

Approximately 20%. International Mobility required.

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