Director - Device Development - Cerus - San Francisco

Job description
Successful candidate will be responsible for directing the development and life-cycle support activities associated with the UVA illumination device of the INTERCEPT Blood System

Primary Responsibilities:
Responsible and accountable for the UVA Illumination Device programs and projects
Manage a small team of engineers and external partners and contractors
Define strategy for development of next generation illuminators, software, and databases in collaboration with Product Management, Manufacturing, and Deployment/Technical Services
Provide technical and managerial leadership for design, development, manufacturing and ongoing product support
Establish and maintain contracts and relationships with external partners
Responsible for illuminator design control, change control, and control of production and other compliance activities
Author regulatory documents for EU, US, and ROW
Lead cross-functional team on development projects related to the UVA Illumination Device
Address customer feedback and support resolution of customer complaints
Assist suppliers and contract manufacturers in problem solving with respect to components, processes, and equipment.
Identify opportunities for product improvements and cost savings
Participate on other cross-functional development and product support teams for INTERCEPT Blood System
Interacts extensively with peers in Development, Manufacturing, Regulatory, Quality, Sales, Deployment, Technical Services, Product Management, and Project Management.
Ensure that project budgets, timelines, and goals are met

Desired Skills and Experience
BS or MS in Electrical or BioMedical Engineering with a minimum of 10 years experience in development of medical devices, IVD, or laboratory equipment
Practical experience in all phases of medical device, IVD, or laboratory equipment development from concept to commercialization, and encompassing optical, mechanical, electrical, and embedded software systems.
Demonstrated project management, people management, and supplier management skills
Prior experience with managing outsourced design and development partners is a must
Expertise in QSR and ISO 13485 requirements for medical devices
Expertise in harmonized standards and requirements for electrical, mechanical and software products
Experience with Class III medical devices is desirable
Excellent problem solving and trouble-shooting skills
Strong attention to detail and accuracy
Excellent communication skills (encompasses verbal, written, interpersonal, listening)
Flexible -- ability to adapt to changing priorities
Some travel required (< 20%).

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