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Job Description
Join Beckman Coulter Diagnostics as the Director of R&D Assay Development in Microbiology, where you will lead strategic product development initiatives. Collaborate with cross-functional teams to innovate solutions addressing global health challenges, particularly in antimicrobial resistance. This role offers a unique opportunity to impact patient lives and advance healthcare technology.
Key Responsibilities
Develop product portfolio strategies for the product lines
Drive product design, verification, and validation to meet FDA/ISO/EN requirements
Manage complex R&D product development projects
Oversee product development and sustaining of on-market products
Incorporate Danaher Business System tools into daily work
Ensure R&D organization has necessary talent and capabilities
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
Strong people leadership with accomplishments in organizational development and talent management
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 organization such as CLSI
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k)Bonus/incentive pay