Lead Manufacturing Engineer

2 weeks ago


Morrisville, North Carolina, United States Ad Astra Diagnostics Full time
Job Overview

The Lead Manufacturing Engineer at Ad Astra Diagnostics, Inc. (AAD) plays a pivotal role in the development and implementation of manufacturing processes. This position involves leading Continuous Improvement Projects (CIP), pinpointing quality deficiencies, overseeing the qualification of automated manufacturing systems, and conducting statistical analysis of production metrics within a dynamic scientific research environment.

Key Responsibilities
  • Manage the production of various device lines.
  • Supervise the manufacturing of multiple testing lines.
  • Analyze production metrics and conduct time studies.
  • Identify and address gaps in manufacturing and inspection protocols.
  • Establish system-level processes to uphold quality standards.
  • Troubleshoot technical challenges on automated production lines.
  • Ensure compliance with Quality Management Systems (QMS) and maintain operator safety.
  • Enforce current Good Manufacturing Practices (cGMP).
  • Lead engineering change orders.
  • Collaborate effectively with other departments on research and development initiatives.
  • Guide teams on various manufacturing projects.
Qualifications
  • The ideal candidate should be a proactive individual, capable of managing engineering projects and effectively communicating their impact across departments.
  • Experience in an FDA-regulated or equivalent cGMP environment is essential.
  • Ability to thrive in a small, entrepreneurial company setting.
  • 5-10 years of relevant experience.
  • Role expectations will be customized based on the candidate's experience and potential for growth.
  • Experience with Solidworks is advantageous.
About Ad Astra Diagnostics

At AAD, we prioritize our team and our clients. We are dedicated to fostering a culture that encourages creativity, learning, and leadership. Our commitment to innovation has enabled us to develop new ideas and technologies that aim to transform the healthcare sector. We value enthusiastic and driven professionals who are passionate about making a positive impact in healthcare by providing relevant and actionable insights. We strive to create a diverse and inclusive workplace that supports innovation and leverages the talents of our workforce. We seek individuals who bring diverse perspectives, demonstrate integrity, and are committed to the success of our clients.

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