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Director, Engineering and Industrialization Operations

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 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 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.

The Job 

Oversee the Engineering and Industrialization Operations teams and associated initiatives required to support the company’s ability to manufacture Instrument and Assay products by ensuring the proper equipment, processes, and technical expertise exist.  Manage and lead the assigned Engineering and Industrialization teams to include multiple sub-functions.  Ensure required Engineering and Industrialization support and oversight for the manufacture and packaging of the products are available to meet or exceed production targets and product quality.  Manage team objectives to ensure resources are efficiently deployed to meet site objectives, minimize scrap and rework while maximizing OEE, cost of finished goods, and yield, while maintaining product quality.  Manage technical expertise and quality support through leading product investigations, implementation of projects related to failure investigations, customer complaints, or product changes. Provide direct leadership for business critical projects including technology transfer, design, startup, implementation of new equipment, technologies, facilities, and processes.

 

MAIN ACCOUNTABILITIES

 

  1. Manage technical teams to select and review vendors for equipment and raw materials
    1. If possible ensure multiple vendors are approved.
    2. Ensure product specifications are up to date and can be reasonably adhered to.
    3. Participate in vendor performance reviews and vendor audits as required.
    4. Research and evaluate new vendors as required.
    5. Evaluate cost reduction opportunities along with Purchasing for vendors.

 

  1. Manage technical teams to monitor equipment, product, and process performance
    1. Review OEE results, analyze data, and implement improvements as required.
    2. Review in process scrap and act to improve as required.
    3. Review equipment, product, and process non-conformances and determine root cause and corrective actions in an effort to reduce repeat events to minimize scrap and rework.

 

  1. Create clear and concise capital and expense requests
    1. Provide supporting facts and documentation to support project deliverables.
    2. Monitor progress of the projects to ensure they move at the planned pace.
    3. Create and maintain capital and operational annual budgets.
    4. Conduct periodic allocation of departmental resources.

 

  1. Product Technology Transfer
    1. Manage the transfer of new products from R&D to Manufacturing in a scaleable form.
    2. Validate the new processes to meet regulatory requirements and ensure the necessary procedures are in place to order raw materials and to make different batch sizes in order to meet market demand.
    3. Manage and provide technical expertise to projects related to scaling-up production processes in order to meet market demands and reduce cost of goods.
    4. Recommend and monitor the validation of scaled-up processes and automated machinery to meet regulatory requirements.

 

  1. CAPA Investigations and Validations
    1. Manage and provide technical expertise to projects related to investigating failures in current product production or testing processes.
    2. Direct projects that address customer complaints related to product performance. Recommend and monitor the implementation of preventive actions and process improvements resulting from these failure investigations. 

 

  1. Risk Management
    1. Direct projects that are conducted to qualify secondary vendors in order to reduce production and vendor-related risks. Manage the qualification of new vendor lots of base broths to minimize the risk of increased scrap during transitions.
    2. Evaluation product and process risk management associated with new technology and processes and proposed changes to current states.

 

  1. Develop Managers and Teams
    1. Communicate company/group plans, goals, and strategic direction to team members.
    2. Oversee professional development of team members through personal coaching, continuing education, and special assignments.
    3. Help focus team members prepare and run the project/process meetings.
    4. Assist project leaders to close the projects after they have been completed.
    5. Monitor performance and feedback through one-on-one performance reviews, project meetings, and daily contact.
    6. Set and administer standards to ensure fair, productive, efficient operation of teams.

 

KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:

 

  1. Advanced degree (Masters or Ph.D.), preferably in Engineering, Chemistry, or Biological Sciences.
  2. A minimum of 10 years of relevant industry experience and demonstrated improvements.
  3. A minimum of 7 years management experience required.
  4. Leadership: Demonstrated capability to lead and develop teams while obtaining results.
  5. Planning: Demonstrated 1-5 year strategic planning capability.
  6. Management: Demonstrated capability to organize and manage multiple priorities and teams.
  7. Demonstrated problem analysis and problem resolution at both a strategic and functional level.
  8. Demonstrated technical skills in lean manufacturing techniques and process improvement, materials management and production scheduling.
  9. Demonstrated successful Capital project implementation.
  10. Demonstrated strengths in product development and manufacturing process development.
  11. Credibility with interdepartmental support functions, manufacturing, quality, and leadership.
  12. Leading and facilitating departmental and interdepartmental meetings.
  13. Excellent interpersonal and communication skills.
  14. Demonstrated management of high performance teams and a strong team player.
  15. Knowledge of engineering principles, chemistry or materials science, quality management system processes, and manufacturing equipment and processes.
  16. Strong background in leading both small and large scale projects.
  17. Strong customer orientation.
  18. Commitment to company value

 

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

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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