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Manufacturing Process Optimization Specialist

2 weeks ago

Galway, Galway, Ireland beBeeManufacturing Full time €80,000 - €125,000
Job Description

We are seeking a skilled Manufacturing Process Optimization Specialist to lead our contract manufacturing operations. The ideal candidate will have expertise in managing and optimizing contract manufacturing processes, ensuring alignment with industry regulations and company standards.


Main Responsibilities
  • Contract Manufacturing Management:
    • Develop and maintain strong relationships with contract manufacturing partners to ensure compliance with company requirements and industry standards.
    • Oversee and manage the entire contract manufacturing process, execution, and continuous improvement initiatives.
    • Coordinate with contract manufacturers to address and resolve production issues and implement corrective actions as needed.
    • Research, justify and propose capital equipment and/or processes investments to improve efficiency and reduce costs.
    • Liaise with the Sourcing group to identify new suppliers and opportunities for cost reduction and quality improvements.
    • Coordinate with Purchasing and Quality Engineering to improve Quality Systems procedures relating to suppliers.
  • Process Optimization:
    • Collaborate with internal teams to review and optimize manufacturing processes and product designs to enhance efficiency and reduce costs.
    • Analyse production data and metrics to identify areas for improvement and implement solutions to optimize manufacturing operations.
    • Perform process capability assessments and develop strategies to improve yield and reduce defects.
    • Provide input and guidance to new product Introduction teams on best practices for MFG production, test, and packaging processes and procedures.
  • Quality Assurance:
    • Develop and implement quality control procedures to ensure products meet design specifications and industry standards.
    • Liaise with Supplier Quality Engineering and Sustaining Engineering (CAPA) to ensure the effective completion of Supplier Corrective Actions. Support the assessment of non-conforming products received from suppliers.
    • Provide technical support and input when required to the Suppler Audit process and liaise with Suppliers and Regulatory Assurance to obtain supplier-related information required for regulatory submissions.
  • Project Management:
    • Lead manufacturing projects from initiation through to completion and resource allocation.
    • Prepare and present project reports, including progress updates, performance metrics, and recommendations for improvements.
    • Ensure projects are executed on time, within scope, and within budget constraints.
  • Technical Support:
    • Provide technical guidance and support to contract manufacturers regarding manufacturing processes, equipment, and materials.
    • Troubleshoot and resolve technical issues related to production processes, equipment performance, and product quality.
    • Give technical guidance to Associate Engineers, technicians, and production employees.
  • Compliance and Documentation:
    • Ensure that all manufacturing activities comply with industry regulations, company policies, and safety standards.
    • Maintain comprehensive documentation related to manufacturing processes, quality control measures, and project activities.
    • Develop and execute validation protocols (e.g., IQ, SV, TMV, MVP, MVR) in compliance with regulatory requirements.
    • Develop manufacturing procedures to support transferred manufacturing processes.
    • Review and approve documents prepared by sister sites or contractors (e.g., Tool Validation report, Risk Assessments, Change Notes).
Qualification Requirements
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Education and/or Experience:
    • Formal Production/Engineering qualification and relevant experience in at least one of the following areas: Manufacturing, Supplier Engineering, Engineering/Device Design & Development.
    • 5+ years of medical device experiences supporting manufacturing, engineering, or quality, regulatory, and/or compliance capacity.
    • Strong knowledge and demonstrable experience of working to medical device quality standards ISO13485/FDA practices and similar regulated industry standards.
    • Project Management and problem-solving skills
    • Proficiency in engineering software and tools (e.g., CAD, ERP systems).
  • Travel Required: Travel is required with this role.