Sr Process Engineer

Company: BioFire Diagnostics
Location: San Jose
Posted on: May 26, 2023

Job Description:

The Company The world is facing a medical crisis; bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases > 6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.Specific Diagnostics has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Specific's elegant, unique, and low-cost solution provides results 2 days sooner (1 day vs 3 days).The JobThe Sr. process engineer will be responsible for:

• Must have the ability to succeed in a fast-paced environment: Be flexible and adaptable within a changing and dynamic environment with ambiguous scope.
• Partner with cross functional teams to evaluate new product, processes, and equipment design at concept phase and define manufacturing processes.
• Develop new and/or improved processes for parts and assemblies through the application of theoretical and practical engineering.
• Coordinate and perform process characterization studies & DOE's to develop new and/or improve existing assembly processes.
• Test, and validate new automation processes and/or designs in collaboration with a diverse functional team of engineers and scientists.
• Write Verification/Validation protocols (IQ/OQ/PQ) and related technical reports to support the transfer of new products, processes, and equipment into production.
• Perform failure investigations and root cause analyses as they relate to process performance.
• Use statistical analysis, and hands-on bench or line testing to characterize attributes, process performance, and equipment assembly characteristics.
• Create and/or update SOP/DOP and train MFG personnel to new processes and automated equipment during product transfer phase.
• Drive data review and electronic documentation change control processYouShould be a self-motivated individual who is highly organized and flexible. You should be comfortable working with a variety of equipment types and feel comfortable working independently.
  • Minimum Bachelor's degree with 7+ years of relevant work experience OR Master's degree with 5+ years of relevant work experience OR equivalent combination of education and experience to perform at this level.
  • Hands on experience with high volume automated manufacturing equipment.
  • Previous working experience supporting manufacturing lines in high volume medical device manufacturing environment.
  • Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.
  • Experience with lean manufacturing and Six Sigma techniques (5S, MUDA, Kaizen, Visual Management, Daily management)
  • Basic mechanical and electro-mechanical troubleshooting skills of automated manufacturing equipment
  • Proven experience with DOE creation, root cause analysis, process engineering, failure investigations and automated assembly equipment.
  • Experience in process development, acceptance testing and qualification of automated equipment.
  • Proficient with performing root cause analysis (fishbone diagram, 5-Whys)
  • Experience with Quality Management System and electronic document change control required.
  • Must have strong computer skills, including all MS Office applications, electronic NCs, ERP system, learning portal and training.
  • Must be proficient in document preparation and editing, including detailed test planning and report writing.
  • Excellent verbal and written communication skills to present summary data to cross functional team
  • Experience with statistical analysis software (MiniTab or similar)
  • Experience with updating BOMs, product specifications.
  • Project management experience would be a plus.BENEFITS:The estimated salary range for this role based in California is between $122,400 and $152,400 annually. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer. In addition, bioM--rieux offers a competitive Total Rewards package that may include:
    • A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
    • Company-Provided Life and Accidental Death Insurance
    • Short and Long-Term Disability Insurance
    • Retirement Plan including a generous non-discretionary employer contribution and employer match.
    • Adoption Assistance
    • Wellness Programs
    • Employee Assistance Program
    • Commuter Benefits
    • Various voluntary benefit offerings
    • Discount programs
    • Parental leavesJob Type: Full-time, M-F 9 am - 5 pm.

Keywords: BioFire Diagnostics, San Jose , Sr Process Engineer, Engineering , San Jose, California