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Associate Principal Equipment Engineer

Location: San Jose, CA, United States
Position Type: Unfixed Term
Job Function: Supply Chain

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

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 a subsidiary of bioMérieux has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific’s solution provides results 2 days sooner (1 day vs 3 days).

We offer an opportunity to join us at an inflection point in our commercial growth, with our first commercial product being released new venture capital funding and recognition from major customers and government agencies fueling an expansion of our staff.

 

POSITION SUMMARY

 

Provide support for equipment related projects within the Sensor Manufacturing Engineering Department. This includes leading and documenting projects from start to finish.

 

PRIMARY DUTIES

  1. Main accountabilities are to lead and manage equipment related projects and to provide machine design expertise for new equipment design and modification of existing equipment.
  2. Develop equipment concepts and designs for new equipment and modifications of existing equipment including documentation as required such as requirements documents, equipment drawings, equipment parts lists, etc.
  3. Develop and execute change controls and other compliance related documentation for equipment including qualification protocols, and facility/utility requirement.
  4. Collaborate with Engineering, Manufacturing, Purchasing, and Quality to lead projects and ensure the optimum manufacturing process in terms of keeping manufacturing moving.
  5. Develop and release equipment related maintenance and calibration procedures. Train technician to perform these procedures and ensure proper documentation and records.
  6. Participate in the development of long-term strategies for equipment and process improvements.
  7. Conduct feasibility studies to assess new technologies or process improvements in equipment design.
  8. Support root cause analysis and fishbone activities related to equipment or manufacturing processes.
  9. Provide timely and accurate reporting on projects.
  10. Ensure all activities comply with Good Manufacturing Practice (GMP), ISO, and Quality System requirements.
  11. Ensure that all health, safety, and environmental requirements are fulfilled.
  12. Support any project or task that requires keeping manufacturing running, and ensure quality product is being shipped to customers.

 

KNOWLEDGE, EXPERIENCE & SKILLS

  • Bachelor’s degree is preferred
  • 10+ years of mechanical or machine design work experience.
  • 10+ years project management experience is preferred.
  • 5+ years of experience using SolidWorks 3D Solid Modeling Cad Software
  • Proven experience in conceptualizing new machine designs and improvements to existing equipment.
  • Ability to collaborate professionally with all levels of management in a cross-functional team environment and equipment vendors is required.
  • Knowledge of FDA/ISO regulations and process validation is preferred.
  • Strong Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
  • Must have strong communication and interpersonal skills.
  • Must have strong analytical and problem-solving skills.

 

 

IMPACT / MANAGEMENT SCOPE

 

Manufacturing floor decisions with regard to equipment changes, specific equipment design and builders, budget, suggest and make decisions based on equipment improvements.

 

WORKING CONDITIONS

 

Extensive standing, repetitive hand and arm motions, ability to climb steps.

Lifting (up to 50Lbs) and moving containers of cartons, tubes, and printed materials.

Must be able to push a wheeled cage that can weigh up to 600 lbs fully loaded.

Operating within cool temperature and low humidity conditions within the production room.  Constant noise is common due to the operation of the air-dry chamber, taping and pouching equipment. 

Excellent personal hygiene required.  Appropriate gowning requirements necessary for the production areas.  Gloves are required to handle the product. Hairnet, clean room gowns and/or lab coats are required. Safety glasses and hearing protection are required personal protective gear. 

Occasional environmental odors may be prevalent. 

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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