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 Sensor Manufacturing Manager is a key member of the operations management team who will lead and direct all associated activities within the Sensor manufacturing department. This role is accountable for ensuring a safe work environment, effective cost management, and on time product delivery product quality. This is a hands-on position, and the selected candidate will lead by example, be willing to work on the production floor and perform Gemba walks.

Core Job Responsibilities:

• Participate as a key member of the operations management team by proactively engaging cross-functionally to achieve manufacturing goals.
• Build an effective team: Manage staff resources by recruiting, selecting, orienting, and training and developing associates for growth opportunities Maintain and encourage inter-departmental communication. Delegate as necessary to grow and develop team members and ensure efficient output of tasks
• Recruit and hire to ensure adequate resource to scale up production with multiple lines and shifts to meet increasing demand
• Resolve personnel issues by analyzing data; investigating issues; identifying solutions; recommending action.
• Ensure a safe working environment for all employees. Monitor safety performance ensures root cause analysis is completed on injuries to prevent recurrence, and assures compliance with established policies, procedures, and goals

• Responsible for timely and effective completion of manufacturing activities to support on time delivery of product.
• Demonstrate high flexibility to adapt to changing business environments and effective at handling multiple projects simultaneously and in a timely manner.

• Provide oversight and management of sensor manufacturing and finished goods packaging to meet business objectives.

• Develop metrics and execute strategy for improving the safety, quality, delivery, inventory, and productivity KPIs.
• Provide regular updates to management about any challenges or delays in meeting production deadlines.
• Report progress and necessary counter-measures to achieve set goals through Daily Management walkthroughs
• Maximize the performance of Value Streams by implementing and sustaining lean conversion principles to meet customer requirements.

• Accountable for adherence to the cost center budget, and development and

management of Capital expenditures for Manufacturing

• Ensure compliance with OPEX budget (labor and operating costs).

Qualifications:

• Minimum Bachelor’s degree with 8 years of relevant experience in medical device regulated manufacturing environment, or Master’s degree with 5 years of relevant work experience of relevant experience in medical device regulated manufacturing environment, or equivalent combination of education and experience to perform at this level.
• Leadership: Ability to influence decision making with or without authority, facilitate groups with diverse perspectives, bring teams to agreement.
• Communication: Interpersonal skills that build productive relationships and influence others,

both within the business and across organizations. Ability to interact with all levels of the

business (senior leaders to working teams), exceptionally good listening skills, able to

present complex or new ideas with clarity and simplicity.

• Teamwork: Collaborate effectively with others in the spirit of common objectives
• Planning and Execution: Excellent project management and prioritization skills. Be able to deliver results despite shifting environment
• Analytical Problem Solving: Ability to identify problems; apply structured and disciplined methodology to identify root cause using data. Apply innovative and effective solution to mitigate risk.
• Hands-on experience with Lean / Six Sigma Problem solving tools: LEAN Manufacturing, Standard Work, Kaizens, Kanban, 5S, MUDA, Visual Management, Daily management
• Must have the ability to succeed in a fast-paced, goal oriented and time-sensitive environment: Be flexible and adaptable within a changing and dynamic environment with ambiguous scope.
• Experience with high volume automated manufacturing equipment.
• Experience with scaling up manufacturing lines and adding shifts in high volume medical device manufacturing environment
• Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.
• Experience with participating in Quality audits and with preparing manufacturing personnel for regulatory audits

• 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 updating SOP/DOP/WI
• Knowledge and experience with IQ, OQ and PQ validations of semi-automated equipment for high volume manufacturing environment

The estimated salary range for this role based in California is between $126,100 and $151,300 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, bioMérieux 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 leaves