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Grifols Shared Services North America, Inc Director, R&D Instruments in San Diego, California

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Summary:

Director, R&D Instruments is responsible for leading a group (or groups) of Engineers / Technicians working on complex projects in in-vitro diagnostics (IVD) and other clinical diagnostic systems comprising of software, instrumentation hardware, assays and disposables; leading development in cross-functional project teams.

He/she shall be relied on as a subject matter expert, to plan development activities, solve in-depth and cross-functional problems or scientific/technical challenges utilizing expertise in systems development and integration of software, hardware, reagent and consumable components.

This role focuses on one area of R&D Instruments comprising related projects.

Primary responsibilities for role:

●Manage groups of engineers/Technicians responsible for different projects who represent R&D Instruments on Core Teams (including system engineering, Software engineering, and V&V Engineering).

● Leads complex system design or evaluation of OEM partner’s efforts using systems engineering expertise.

● Manages and develops the team of system, Software and V&V engineers.

● Interacts with outside partners and vendors work and progress towards specifying and developing and interfacing diagnostic systems, including architecture, design, prototype testing, defect reviews, design reviews, V&V and UAT.

●Seen as a leader by effectively managing junior level employees and communicating and collaborating with colleagues at all levels and in all departments of the organization.

●Manage a portion of the overall R&D Instruments budget in line with corporate guidelines.

●Lead improvement activities (reducing waste and increasing Quality) developing and improving SOPs related to R&D Instruments, product development and design control.

●Interacts with upper management in communicating project status, issues and resourcing.

● Leads the team to Apply working knowledge of network connectivity and cybersecurity requirements for IVD and clinical diagnostic platforms.

  • Represents R&D Instruments on Core Teams for complex product development projects or in support of on-market products.

  • May be called on to represent the Company at conferences (presenting or attending) or with regulatory bodies.

Additional Responsibilities:

  • Responsible for leading and managing a group of R&D Instruments engineering team.

Knowledge, Skills, and Abilities:

  • 12+ years of relevant experience in R&D / engineering or product development and experience developing medical diagnostic products.

  • Demonstrated ability to effectively manage a group of diverse individuals to move projects forward.

  • Ability to lead the complex systems issues and problems solving.

  • Experience with leading development efforts in a cross functional environment.

  • Demonstrated product development experience under FDA design control.

  • Experience in large scale projects requiring architecting and developing systems which include instrumentation, software, reagents and consumables.

  • Manage execution.

  • Build realistic plans.

  • Promote teamwork.

  • Share the vision.

Education:

B.S/B.E. or graduate degree in Engineering or Biotechnology or equivalent disciplines.

Experience:

B.S/B.E. 12+ yrs or MS /ME 10+ yrs

Equivalency:

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Req ID: 246927

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