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Job Description
Beckman Coulter Diagnostics is seeking a Director for R&D Assay Development in Microbiology to lead innovative product development and drive operational excellence. The role requires a strong R&D background and leadership skills to meet evolving customer needs while ensuring compliance with regulatory standards.
Key Responsibilities
Collaborate with senior management to develop product portfolio strategies
Drive robust product design, verification, and validation
Manage complex R&D product development projects
Oversee product development and sustaining of on-market products
Establish a data-driven culture of accountability
Ensure necessary talent and capabilities within the R&D organization
Required Qualifications
Advanced degree (Masters or Ph.D.) in bioengineering, fluidics, mechanical, electrical, software, or systems engineering
14+ years of experience in product development, preferably in analytical, scientific, or diagnostic instrumentation
4+ years in R&D management, preferably in a regulated environment
Experience in lean tools and leading Kaizens
Knowledge of FDA CFR820 and ISO 13485
Strong people leadership and talent management skills
Effective problem solver and data-driven decision maker
Preferred Qualifications
Experience with Antimicrobial Susceptibility Testing Breakpoint setting organization such as CLSI
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k)Bonus/incentive pay