Manager, R&DSEKISUI Diagnostics is looking for a Manager, R&D to join our MDx team.
What you'll do: As Manager, R&D you will build out and lead a team focused on product development for novel, point of care, molecular diagnostics devices that help further our company's mission of providing intelligent solutions to enhance life through science and improve the health of all people.
Reporting to the Associate Director, R&D, you will have the unique opportunity to build out and lead an R&D team responsible for test method development, verification, and validation in a new and quickly growing business unit. You will manage, plan, and direct the research and development efforts to conduct Assay Verification and Validation studies for FDA 510k submissions and to meet organizational needs and to capitalize on potential new products. You will develop and implement research and development procedures and techniques. You will be responsible for oversight of complex research projects, analyzing results, providing recommendations based on findings, and ensuring projects stay on time and within budget.
To be successful in this role, you should be a highly driven technical manager with a passion for problem-solving, a proven track record of successfully developing molecular diagnostics assays, exceptional organization skills, and a keen eye for detail. The ideal candidate will have POC Molecular Diagnostics Verification and Validation study experience for 510k submissions.
What you'll need: - Experience overseeing the Verification and Validation phases of new MDx product development under Design Control-QMS
- Direct experience with writing Validation Study Protocols and Reports including data analysis, data presentation, and data auditing
- Knowledge of the undertakings required to support Clinical Method Comparison Studies
- Have participated in FDA 510k submissions Dual 510k-CLIA-waiver and FDA Q&A
- Understanding of statistical usage during product development, and/or familiarity with stat software (JMP, Minitab, SAS)
- Experience in an FDA regulated R&D environment for IVD Molecular Assay Development
- Instrumentation experience - experience having worked on an FDA cleared assay with a consumable and FDA cleared instrument preferred
- Capable of managing a technical team of 2-3 in a fast-paced Product development lab environment
Bonus skills and experience:- Familiarity with bioinformatics software packages/servers preferred
- Experience designing and conducting Flex studies to support CLIA-waiver requirements
- Microfluidic/consumable design comprehension preferred
- Background in Infectious disease
- Hands-on experience with microorganisms
What you'll get: Competitive compensation and benefits; flexible schedule, a culture that embraces diversity and inclusion, opportunities for growth, and a collaborative work environment with awesome employees!
