Avails Medical, Inc., is a well-funded medical device start-up based in Menlo Park, California. We are a leader in the development of rapid, automated and fully electrical antibiotic susceptibility testing (AST) technologies with our products eQUANT™ and eAST™ platforms based on a novel bio-sensor for rapid infectious disease detection. In 2024, we have announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for our groundbreaking eQUANT™ system. The eQUANT™ system is a leap forward in combating antibiotic resistance, providing a standardized inoculum (0.5 McFarland equivalent) directly from positive blood cultures.
We are dedicated in our drive to make rapid AST accessible and affordable to hospital microbiology labs, empowering them to provide actionable infectious disease treatment information with simplified laboratory workflows to save lives, reduce outcome costs and reduce the threat of global antimicrobial resistance.
Job Description for Manufacturing Engineer
Reports to Director of Manufacturing
Key Responsibilities:
Develop and execute scalable manufacturing strategies that support the company's business objectives and meet regulatory requirements.
Assess and enhance assembly, test and packaging processes at internal facilities, supplier locations, and contract manufacturing sites.
Lead design for manufacturability (DFM) initiatives, providing critical feedback and manufacturing insights to engineering teams to refine product designs and drive innovation.
Create detailed specifications for tooling and equipment suppliers and oversee the design, fabrication, and implementation of fixtures, gauges, and automation systems.
Design efficient factory layouts for assembly, testing, and packaging equipment, ensuring optimal workflow and material handling.
Develop comprehensive work instructions for internal assembly and testing processes and review and approve work instructions created by contract manufacturers.
Conduct root cause analysis of nonconformances and lead corrective and preventive actions to uphold quality standards.
Compile and analyze production data, documentation, and system information, authoring detailed reports for internal use or regulatory submissions.
Desired Qualifications:
Bachelor's or Masters degree in Manufacturing or Mechanical Engineering, with at least 8 years of industry experience.
Proficiency in CAD software, especially SolidWorks.
Strong understanding of material characteristics and properties.
Hands-on experience with assembly processes, electrical systems, and machine shop practices.