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Software Quality Engineer

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

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 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 than existing methods, saving patients suffering from drug-resistant infection. 

We have been funded by nearly $30 M in non-dilutive government sponsored research support and recently $17.5 M in venture capital. This is an opportunity to join us at an inflection point in our commercial growth as we bring our first key product to market and with recognition from major customers fueling an expansion of our staff.

The Job

This is the job for you if want to be where your ideas will be central to world-changing and lifesaving products. The role includes contributing to product requirements and execution of the software and system verification testing to confirm system performance to product specifications. We are making a lifesaving medical instrument, so software test, verification and validation is a critical to our development and company success.

You will be a key contributor in a fast track development program for a medical diagnostic system, and experience in product development of FDA-regulated medical devices in an ISO 13485 quality environment is required. The role includes assuring software in compliance with medical device software standards including IEC 60601 & 62304. Use of tools such as Jira and Arena for documentation of defects in a maintained issue tracking database will be a routine task.

This role is a key member of our development team, responsible for development, execution, and debug of test software based on software requirements and technical specifications. The job includes creation of test cases, development of test software and verification of results against requirements.

You

You must have exceptional written, verbal and presentation communication skills.  A sample of your written technical work product will be required in the hiring process.  You should have direct experience in the engineering development of software, test software, verification and validation of regulated medical devices and these qualifications:

  • Experience in C, C# and Python
  • Minimum 3 years of experience in automated testing, using, SW test frameworks
  • Bachelor Degree in Computer Science, Electrical Engineering, or other related field preferred.
  • Experience with source control and defect tracking systems (Github, Jira, etc.)
  • Must possess excellent written and verbal skills to communicate with the development team
  • Must be able to work independently as well as in a team environment
  • Previous automated script design, coding, debugging and maintenance skills are a must
  • Experience with IEC 62304 medical device development, test, and documentation

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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