Manufacturing and Process Development Expert

2 weeks ago

Galway, Galway, Ireland beBeeDevelopment Full time €70,000 - €85,000
Manufacturing Development Manager

Job Description:

The successful candidate will lead the manufacturing development process for a cutting-edge medical device company. Key responsibilities include technical leadership of product transfers, developing and implementing manufacturing capabilities using lean principles, and working with quality teams to ensure compliance with ISO 13485 and other relevant standards.

Responsibilities:

  • Technical leadership of manufacturing transfer of new products and changes to existing products
  • Develop and implement manufacturing capabilities using lean principles and tools
  • Work with quality teams to manage NCMRs and CAPAs, conduct supplier monitoring and audits, and ensure compliance with regulatory requirements
  • Contribute to the execution of departmental and company goals
  • Update stakeholders on objectives, projects, and goals, particularly cross-functional business objectives
  • Support business partners by providing technical leadership for long-term manufacturing and distribution channels
  • Develop commercial manufacturing timelines consistent with project and regulatory needs
  • Financial modeling for COGS and scaling up production capacity
  • Technology transfer to partner or contract manufacturing organizations
  • Promote and support continuous improvement culture and drive cost-saving initiatives

Required Skills and Qualifications:

The ideal candidate will have a Bachelor's degree in engineering or a related field with at least 7 years of experience, including 3 years in a technical leadership role in a biotechnology, pharmaceutical, or medical device industry. The candidate should have experience working within ISO 13485/FDA regulated quality systems, with a proven track record in manufacturing and process development in a regulated environment.

Benefits:

This is a hybrid role that requires working closely with suppliers and collaborating with cross-functional teams. The successful candidate will be able to achieve results in a virtual organization and have excellent analytical and decision-making skills. The role offers opportunities for professional growth and development in a fast-paced, high-growth environment.

Others:

The candidate should be a seasoned professional in manufacturing and engineering development with knowledge and skills in design for manufacturability, technology evaluation, driving innovative solutions to complex problems, process design and development, materials, and design for six sigma principles.

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