Key Process Development Manager

3 days ago

Galway, Galway, Ireland beBeeManufacturing Full time €100,000 - €120,000

Our client is seeking a key team member to lead the manufacturing and process development of innovative medical devices. This hybrid role will work closely with a Galway based supplier, requiring on-site presence 3 days per week.

Responsibilities:

  • Lead the transfer of new products and changes to existing products into manufacturing using design for manufacturability concepts.
  • Develop and implement manufacturing capabilities using LEAN principles and tools.
  • Collaborate with quality teams on NCMR's, CAPA's, supplier monitoring, audits, risk management, and internal controls to ensure ISO 13485 compliance.
  • Contribute to departmental and company goals through successful project execution.
  • Regularly update stakeholders on project objectives, timelines, and cross-functional business objectives.
  • Provide technical leadership for long-term manufacturing and distribution channels.
  • Develop commercial manufacturing timelines and financial models for COGS and production capacity scaling.
  • Transfer technology to partner or contract manufacturing organizations as applicable.
  • Promote a continuous improvement culture and drive cost-saving initiatives.

Requirements:

  • Bachelor's degree in engineering or related field with at least 7 years' experience, including 3 years in a technical leadership role in a biotechnology, pharmaceutical, or medical device industry.
  • Experience working within regulated quality systems with ISO 13485/FDA knowledge.
  • A proven track record in manufacturing and process development in a regulated environment, preferably in medical device catheter products.
  • Ability to achieve results in a virtual organization, with experience working with cross-functional teams and completing projects on time.
  • Strong passion for Engineering concepts and principles, with excellent analytical and decision-making skills.
  • Flexible approach to problem-solving, adept negotiation, and risk-based decision-making.
  • Strong organizational, communication, interpersonal, managerial, and leadership skills.
  • Ability to effectively manage consultants, suppliers, vendors, and budgets.

Preferred Skills:

  • Knowledge and skills in DFM, technology evaluation, driving innovative solutions, process design, materials (polymers and metals), design for six sigma principles, CAD, statistical techniques, process validation, and control, along with Manufacturing KPIs.

What We Offer:

  • Opportunity to work with cutting-edge innovative devices significantly advancing healthcare.

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