Grifols Shared Services North America, Inc Director, R&D Instruments in San Diego, California
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.
- 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.
Build realistic plans.
Share the vision.
B.S/B.E. or graduate degree in Engineering or Biotechnology or equivalent disciplines.
B.S/B.E. 12+ yrs or MS /ME 10+ yrs
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