Director/Associate Director, Device Development



  • United States 
  • Last Update: 13.01.2020 at 12:00

Job Type
Full Time
6 Month +
Concord, CA, US
United States


Responsible for development and manufacturing support for the INTERCEPT technology platform. Scope includes new product development, product improvements, cost savings projects, and other manufacturing initiatives, with a focus on single-use disposable Class III medical devices.

Primary Responsibilities
  • Lead or participate in new product development, product improvement and ongoing sustaining projects for commercial INTERCEPT products, as assigned.
  • Partner with Product Management, Project Management, Development and others on concept and feasibility studies to demonstrate proof-of-principle for new product or improvement opportunities. Define and execute studies and validation plans, including both hands-on laboratory experiments and manufacturing studies.
  • Participate and present on Cerus cross-functional teams.
  • Manage external suppliers and contract manufacturers to meet project timelines and drive development and manufacturing activities to completion.
  • Manage engineering staff including daily activities, deliverables, employee development, training and performance management.
  • Partner with management on annual planning, budgeting and forecasting for device development equipment and staffing.
  • Release new or revise existing documentation into the Cerus Document Control System.
  • Create Cerus specifications for raw materials, components, and finished goods.
  • Fabricate or procure prototype components for development testing, as needed.
  • Author or review portions of IDEs, Regulatory Change Notifications, and/or Design Dossiers, as needed.
  • Assist suppliers and contract manufacturers in problem solving with respect to components, processes, and equipment, and test methods.
  • Support resolution of customer complaints for disposables.
  • Lead or Support Design Reviews and create or maintain project specific Design Control/Change History files, as assigned. Support product risk management activities for INTERCEPT products.
  • Ensure that project budgets, timelines, and goals are met.
  • Participate in Human Resources activities of the department (staffing, performance management and employee development).
  • Bachelors or Master's degree in chemical, materials, or biomedical, engineering with minimum 10 years of medical device development experience.
  • Minimum of 3 years people management experience with demonstrated leadership skills.
  • Ability to influence and work effectively with cross-functional groups.
  • Ability to leverage own expertise and input from others to identify issues and make recommendations that address overall corporate and/or program needs.
  • Demonstrated success in working with suppliers and contract manufacturers.
  • Knowledge of QSR, ISO 13485, ISO14971 and MDR requirements for medical devices is a must; knowledge of GMP requirements for medical device and pharmaceuticals is desirable.
  • Experience with authoring and review of regulatory submissions
  • Experience working in and managing laboratory facility (chemical and physical methods) is required
  • Experience with flexible plastic containers, injection-molded components, and sterilization technologies is required.
  • Experience in development of combination products is desirable. .
  • Ability to work on complex issues where analysis of data requires an in-depth evaluation of variable factors.
  • Ability to exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Strong project management skills.
  • Highly-motivated team player.
  • Creative, innovative approach to problem solving.
  • Attention to detail and accuracy.
  • Excellent communication skills; effectively interacts with others at all levels internally and externally.
  • Flexible; ability to adapt to changing priorities.
  • Some US and international travel required (

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