What are the responsibilities and job description for the Manager, R&D position at Sekisui Diagnostics?
Manager, R&D
Would you like to join a cutting-edge firm in the life sciences field?
SEKISUI 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!
Who are we:
At Sekisui Diagnostics, we help improve patient outcomes by doing what we've always done - focusing on innovating and developing highly accurate diagnostics tests, reagents, and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers - and customize solutions at both a regional and product level.
Come join us! Please apply for immediate consideration.
Equal Opportunities
As an equal opportunity employer, SEKISUI Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job-related characteristics, or other prohibited grounds specified in applicable country and local laws. It is also SEKISUI Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.
SEKISUI Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.