Manufacturing Engineer

CytoVale

San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 02/12/2021
  • Website: cytovale.com
  • Company Address: 150 Executive Park Blvd Suite 4100, San Francisco, CA, 94134

About CytoVale

Cytovale, based in San Francisco, Calif., is a medical technology company dedicated to revolutionizing diagnostics using cell mechanics and machine learning, and applying this first to sepsis, a condition whose early detection dramatically improves patient outcomes.

Job Description

As the Manufacturing Engineer you will be a key member of the Operations department reporting to the Sr. Director. Span of responsibilities includes supporting Design Control activities for 510(k) submission through design freeze, Verification & Validation, and managing external process validations. Support our Contract Manufacturers (CMs) to ensure Supply, Quality, and Cost targets are achieved for successful clinical operations, and commercialization.

Product category responsibilities may include low-volume complex diagnostic equipment assembly, and/or high-volume consumable cartridges, reagents, and packaging/labeling. Activities may be a blend of tactical sustaining tasks, strategic supplier development projects, as well as Design for Manufacturability (DFM) and next-generation product/process development.

 

RESPONSIBILITIES

  • Represent Cytovale as the primary technical point of contact for our Contract Manufacturer(s)
  • Proactively identify and lead capacity expansion projects necessary to fulfill MFG forecasts
  • Support/lead technical projects to improve Quality and reduce Cost
  • Lead/manage Design Control deliverables associated with establishing reliable MFG processes & risk management
  • Support MFG non-conformance root cause analysis investigations and mitigations
  • Partner with internal QA and CMs to establish/maintain effective component incoming QC inspection, in-line process validations & monitoring, and lot release testing
  • Partner with R&D ENG in assessing, developing, implementing DFM opportunities, and mitigating component obsolescence
  • Support/lead projects to qualify additional/alternative CMs as necessary

 

MINIMUM QUALIFICATIONS

  • BS degree in related Engineering or Technical field
  • 3-5 years of experience in FDA regulated industry
  • Effective experience with developing product specifications, MFG Work Instructions, MFG Deviations, Non-Conformance Reports, CAPAs
  • Effective experience with Risk Management (PFMEA); Process controls & monitoring, and Validation
  • Proficiency reading, reviewing, and understanding Engineering Drawings
  • Effective at critical thinking and managing complex projects
  • Good organizational skills as well as strong written/verbal communications skills that could be used successfully in negotiation, influence, and conflict management
  • The ability to prioritize tasks, drive process improvements and thrive in a fast-paced environment

 

PREFERRED QUALIFICATIONS

  • Experience developing/manufacturing In Vitro Diagnostics (IVD)
  • Experience with Contract Manufacturers / Vendor Management
  • Principles of Design For Manufacturability (DFM)
  • Test method development and Validations
  • Prior experience in application of sampling plans and other statistical techniques desirable

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.