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Senior Sensor Manufacturing Process Engineer

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

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 (>52%) 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 bioMerieux company, has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific’s Reveal system provides results 2 days sooner (1 day vs 3 days).

This is an opportunity to join us at an inflection point in our business as we grow in the EU and prepare for launch in the US.

 

The Job

The senior manufacturing engineer will be responsible for transferring assay manufacturing line from R&D to operation, sustaining and improving process flow and work instructions. This position will act as technical lead in manufacturing process, and work with cross functional teams to validate and scale manufacturing line to high volume with consistent and high quality.

The assay is based on chemical sensing of small volatile organic compounds. Manufacturing of the assay includes formulation of the sensing compounds, precise printing and final assembly.

 

Core Job Responsibilities:

  • Lead design transfer and process validation for sensor manufacturing line. Create, execute and complete validation and qualification (IQ/OQ/PQ) documents for GMP
  • Develop/improve manufacturing work instruction and responsible to train manufacturing staffs to ensure quality products.
  • Develop/improve manufacturing workflow with lean and high efficiency practice.
  • Establish process controls, statistical measures of manufacturing performance and quality
  • Perform nonconformance investigation and failure analysis for sensor manufacturing line
  • Conduct time study and technical assessment for manufacturing capacity and continuous improvement plan.
  • Comply to GMP and GDP principles and QMS documentation requirement.
  • Other duties or support assigned by the manager


Qualifications :

  • Minimum of 5 years of experience in medical device or other regulated manufacturing environment. AS/BS in chemistry, engineering or related field.
  • Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment.
  • Familiarity with FDA QSR and ISO 13485 medical device regulations.
  • Led successful manufacture of at least two products preferably with ISO 13485 control requirements and high volume manufacturing line.
  • Strong oral and written communication and presentation skills. Effective communicator of technical & non-technical information.
  • Experience with lead and execute validation and design transfer, ex: IQ/OQ/PQ.
  • Strong project or program management skill and experience is preferred.

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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