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Executive Director Quality and Manufacturing

1 month ago

Dublin, Ireland ShiraTronics, Inc. Full time
Executive Director Quality and Manufacturing

ShiraTronics is seeking an Executive Director Quality and Manufacturing, reporting to the Vice President Quality and Regulatory Affairs, Leo Toay. As a key member of the Executive Team, the Executive Director Quality and Manufacturing will provide the direction and leadership for defining the long-term company strategy for manufacturing the ShiraTronics neuromodulation system in Ireland. The Executive Director Quality and Manufacturing will play a critical role in positioning the company to meet future operational needs as ShiraTronics moves into commercialization of its products.

Overview

The Executive Director of Quality and Manufacturing will lead the effort to evaluate and establish ShiraTronics manufacturing operations in Ireland. This role involves evaluating the potential to build medical devices in Ireland, including site selection, make vs. buy analyses, and staffing. The Executive Director will build and oversee the Irish team, ensuring high-quality standards and regulatory compliance, and will present the strategic operations plan for Ireland to the ShiraTronics board of directors and the senior ShiraTronics leadership team. This role will provide technical support in the selection of suppliers, as well as monitor supplier performance to drive supplier corrective action for manufacturing yield issues and field failures. The Executive Director Quality and Manufacturing will also be a key decision-maker for both selection and implementation of a future ERP system for worldwide company use and will be responsible for leading the existing documentation management function within ShiraTronics.

Responsibilities

  • Engage with Irish governmental agencies and explore funding and support through IDA Ireland for facilities and manufacturing site selection.
  • Develop and present the strategic operations plan for Irish manufacturing to the ShiraTronics board of directors, providing updates on progress, challenges, and opportunities.
  • Oversee the setup and operationalization of an Irish manufacturing site or Irish contract manufacturer, if feasible, ensuring timely and cost-effective execution and compliance with all applicable regulatory, quality, environmental, health, safety, and labor requirements.
  • Develop and manage the Irish operations budget, ensuring cost-effective use of resources and adherence to financial targets.
  • Lead the company-wide documentation management function within ShiraTronics.
  • Provide key input to the selection and evaluation of a future ERP system at ShiraTronics.
  • Strong knowledge and experience in the application of Lean methodologies and in the development of efficient, cost-effective manufacturing equipment and processes.
  • Assess potential new suppliers for technical, quality, and manufacturing capabilities.
  • Research and evaluate mechanical and electro-mechanical materials, components, assemblies, processes, and/or equipment.

Preferred Experience

  • Bachelor’s degree in engineering, Operations Management, or a related field; advanced degree preferred.
  • Proven track record of success in senior operations leadership roles and 10+ years of relevant experience leading and managing operations within the medical device or related industry within Ireland.
  • Active implantable device manufacturing for neuromodulation or cardiac medical devices.
  • Experience with injection molding manufacturing.
  • Strong interpersonal skills with the ability to develop internal and external relationships.
  • Willingness to travel to the United States periodically (3 – 5 times per year).

ShiraTronics is a privately held medical device company located in Minneapolis. Our seasoned team has developed a device that aims to combat debilitating chronic migraine disease. This position will be based in Ireland and will travel occasionally to Minnesota, USA. ShiraTronics offers a competitive salary and benefits package.

Please send your resume and cover letter to careers@shiratronics.com.

Seniority level
  • Executive
Employment type
  • Full-time
Job function
  • Product Management, Production, and Quality Assurance
Industries
  • Medical Equipment Manufacturing
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