Job Information
BioFire Diagnostics, LLC. Sr. Manager, Night Shift in San Jose, California
bioMérieux is a pioneering force in the medical microbiology device industry. Our cutting-edge technologies have been transforming healthcare and improving patient outcomes. We are seeking a highly skilled Automation and Verification Engineer to join our dynamic team, driving robustness of hardware, software, firmware, and algorithms into systems that shape the future of medical science.
POSITION SUMMARY We are seeking a highly skilled and motivated Sr. Manager to lead the team during the night shift (starting at around 2:30 pm) and weekends. As a Sr. Manager you will contribute to and oversee a team dedicated to supporting the development, verification, and validation of the company tests. The ideal candidate will have a deep understanding of microbiology and AST, coupled with strong managerial, collaboration and technical skills to contribute to the growth and success of the Vitek Reveal Platform menu products. C ommunication and collaboration skills are essential, as this position interacts closely with other teams across the department.
PRIMARY DUTIES
Supervise and provide day-to-day scientific, managerial, and organizational structure to a team of scientists and researchers involved in the development of AST assays and microbiology research/testing.
Contribute and participate in the execution of studies assigned to the team as needed.
Provide technical expertise in microbiology, antimicrobial susceptibility, and assay development to drive solutions and high-quality test development.
Provide mentorship, direction, and support to team members to enhance their skills and capabilities. Assign duties, set priorities and ensure team’s performance meets or exceeds company standards.
Ensure that all microbiology testing activities and AST assays developed adhere to relevant regulatory requirements (e.g., FDA, ISO13486 and EU IVDR) and good laboratory practices (GLP). Implement and maintain quality control measures to ensure the accuracy and reliability of the results.
Ensure projects are completed on time, within budget and in compliance within regulatory requirements.
Foster within function and cross-functional collaboration by working closely with R&D teams, QA, Regulatory and other relevant departments to drive product development initiatives forward.
Communicate effectively with stakeholders and upper management (as needed) to provide updates on project progress, milestones, results and any issues or challenges encountered.
Contribute to the writing and review of technical documents, Project related documents, SOPs, WI etc... and prepare presentation materials for communication internally and externally as needed.
KNOWLEDGE, EXPERIENCE & SKILLS
PhD or master’s in microbiology, molecular Biology or related field
Minimum of 5 to 8 years of relevant industry experience. Minimum of 3 years in a managerial role within a medical device diagnostic industry, preferably in the development of AST
Strong understanding of microbiology principles, antibacterial resistance mechanisms and antibacterial susceptibility testing methodologies
Strong data analysis and troubleshooting skills, familiarity with Tableau, JMP or equivalent highly desirable.
Identify opportunity for process optimization and efficiency improvement within the department. Implement best practices, SOPs, and new technologies to streamline workflow and increase productivity.
Excellent leadership, communication, and interpersonal skills
Experience with regulatory submissions and compliance requirements for IVD products (eg. FDA 510k, CE-IVDDR)
Ability to work effectively in a fast-paced dynamic environment with focus on meeting tight deadlines and delivering high quality results.
Ability to work night shifts and weekends as required: Monday through Friday 2:30 pm to 11:30 pm and Saturday/Sunday (10:00 AM to 7:00 pm)
The estimated salary range for this role based in California is between $ 141,400 and $ 169,700 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