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Job Description
Beckman Coulter Diagnostics seeks a Director of R&D Assay Development in Microbiology to lead innovative product development and strategic planning. This role offers the opportunity to drive significant advancements in healthcare diagnostics while managing a high-performing team in a collaborative environment.
Key Responsibilities
Collaborate with senior management to develop product portfolio strategies
Drive product design, verification, and validation to meet regulatory requirements
Manage execution of complex R&D product development projects
Oversee product development and improvements for on-market products
Establish a data-driven culture of accountability
Build and develop a skilled global team to achieve organizational goals
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 in a regulated environment
Strong people leadership and organizational development skills
Experience in lean tools and leading Kaizens
Regulatory knowledge of FDA CFR820 and ISO 13485
Effective problem solver and data-driven decision maker
Preferred Qualifications
Experience with Antimicrobial Susceptibility Testing Breakpoint setting organizations such as CLSI
Benefits & Perks
Paid time offMedical/Dental/Vision insurance401(k) planBonus/incentive pay