Director, Manufacturing Technologies

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Director, Manufacturing Technologies

Durham, NC

July 2022

HemoSonics, LLC is seeking a Director of Manufacturing Technologies who will manage a group of engineers and scientists to provide internal technical support for all HemoSonics Operations activities, including Reagent and Cartridge Manufacturing, Instrument Manufacturing, Supply Chain, and Customer Service.

Key Attributes of the Successful Candidate:

  • Superior analytical skills and advanced troubleshooting abilities.
  • Excellent organizational skills and strong attention to detail.
  • Excellent oral and written communication skills.
  • Knowledge of GMP, ISO and FDA policies and regulations.
  • Knowledge of mechanical and electrical engineering concepts.
  • Proficient with Microsoft Office Software.
  • Proficient with 3D Cad Software.
  • Self-directed and self-motivated.
  • Great communicator internally and externally.
  • Ability to remain calm and operate effectively under pressure.

Key Responsibilities:

  • Lead the Manufacturing Technologies team, which includes identification of goals, prioritization of projects, and day-to-day support.
  • Lead efforts to improve quality and capacity of manufacturing activities, including development of custom equipment and automation.
  • Troubleshoot instrument, cartridge, and reagent manufacturing issues as needed.
  • Perform root cause analysis of manufacturing issues.
  • Implement mitigations and resolutions to address manufacturing issues.
  • Perform verification and validation for changes as needed.
  • Follow non-conformance, CAPA, and deviations processes as needed.
  • Communicate cross-functionally to ensure rapid resolution of Operations issues.
  • Create and/or modify work instructions and procedures as needed.
  • Work with cross-functional teams related to the development and/or improvement of HemoSonics products as well as the transfer of new products to Operations.
  • Work with cross-functional teams related to the development and/or improvement of HemoSonics internal processes.
  • Other duties as assigned by the VP of Operations.

Education and Experience Required:

  • BS Degree in engineering discipline with 10 years’ experience in Medical Diagnostics manufacturing; or equivalent combination of education and experience.
  • Proven record of successfully implementing custom equipment and automation.

This position is based at our facility in Durham, NC and may involve occasional travel to vendor sites, up to 10%. HemoSonics requires employees to be fully vaccinated against COVID-19 or meet requirements for a medical or religious exemption.

To apply, please email your cover letter, resume and salary requirements to:

HemoSonics, LLC is an equal opportunity employer. All applicants will be considered for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Why HemoSonics?

HemoSonics is a growing team of scientists, engineers, regulatory and business professionals all focused on transforming the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care.

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