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Manufacturing Engineer, Lead

2 months ago

Morrisville, United States Ad Astra Diagnostics Full time
Job DescriptionJob DescriptionThe Manufacturing Engineer, Lead at Ad Astra Diagnostics, Inc. (AAD) is responsible for spearheading manufacturing process creation and enforcement, leading Continuous Improvement Projects (CIP), identifying quality gaps, leading qualification of automated manufacturing systems, and providing statistical analysis of production metrics at an exciting and growing scientific research company in the RTP area of North Carolina. This role is expected to be on site, during standard business hours. 

Essential Functions and Responsibilities
  • Oversee manufacturing of multiple device lines
  • Oversee manufacturing of multiple test lines
  • Provide production metrics and perform time studies
  • Identify gaps in manufacturing and inspection procedures
  • Implement system level processes to ensure quality
  • Solve technical issues on an automated production line 
  • Ensure QMS compliance and manufacturing operator safety
  • Enforcement of cGMP 
  • Spearhead engineering change orders 
  • Work synergistically with respective departments on research and development projects 
  • Lead teams on manufacturing projects
Skills and Qualifications
  • The ideal candidate will be a self-starter, comfortable with taking on engineering projects and communicating project impact to respective departments in the company. 
  • Experience operating in an FDA or equivalent cGMP environment a must.
  • Ability to work in an entrepreneurial small-company environment.
  • 5-10 years of experience
  • Role expectations will be tailored to the candidate’s experience and growth potential in the position.
  • Solidworks experience a plus
About AAD
At AAD, we are committed to our team and customers. We believe in fostering a culture that promotes creativity, learning, and leadership. Through our efforts and values, AAD has been able to cultivate new ideas and create new technologies to revolutionize the healthcare industry. We welcome enthusiastic, driven professionals, passionate about positively impacting healthcare by providing relevant, valuable, and actionable information. We are devoted to creating a diverse and inclusive environment in order to best support innovation and the talents of our people. We look for people who bring diverse ideas, demonstrate integrity and show dedication to the success of our customers. We offer competitive benefits, including health, dental, and vision insurance, 401k, and paid vacation.

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