Device Development Manager

Location
Concord, CA
Posted
Sep 07, 2018
Discipline
Engineering
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Responsible for the development, technology transfer and commercial manufacturing support of single-use medical devices for the Class III INTERCEPT technology platforms for Platelets, Plasma, and Red Blood Cells. 

Primary Responsibilities:

  1. Lead or participate in new product development for INTERCEPT projects.
  2. Participate in product improvement and ongoing supply assurance/cost savings projects for commercial INTERCEPT products.
  3. Define and execute studies and validation plans, including both hands-on laboratory experiments and manufacturing studies.
  4. Work with external suppliers and contract manufacturers to meet project timelines and drive development and manufacturing activities to completion.
  5. Work with Quality, Regulatory, Finance, Legal and Project management  to meet project timelines and drive development and manufacturing activities to completion
  6. Participate on Cerus cross-functional teams and present updates from ongoing projects and timelines
  7. Release new or revise existing documentation into the Cerus Document Control System.
  8. Create Cerus specifications for raw materials, components, and finished goods.
  9. Manage technology transfer for INTERCEPT products to contract manufacturer(s) including:  identifying activities and timelines, issuing specifications, reviewing and approving validation plans, and facilitating cross-functional meetings.
  10. Fabricate or procure prototype components for development testing, as needed.
  11. Assist suppliers and contract manufacturers in problem solving with respect to components, processes, and equipment, and test methods.
  12. Support resolution of customer complaints for disposables.
  13. Author or review portions of IDEs, Regulatory Change Notifications, and/or Design Dossiers, as needed.
  14. Lead or support Design Reviews and create or maintain project specific Design Control/Change History files, as needed.  Support product risk management activities for INTERCEPT products.
  15. May supervise lower level engineering staff.

Qualifications/Requirements/Skills: 

  1. Bachelors or Master’s degree in chemical, mechanical, or biomedical engineering with minimum 8 years of medical device/IVD disposables development experience.
  2. Supervisory experience with ability to mentor and guide lower level engineers.
  3. Demonstrated success in working with suppliers and contract manufacturers.
  4. Knowledge of QSR, ISO 13485, ISO 1971 and ISO 2859 requirements for medical devices.
  5. Knowledge of GMP requirements for single-use medical device, including validation, testing, and sterilization requirements.
  6. Expertise in flexible plastic containers, injection-molded components, and packaging systems.
  7. Ability to work on complex issues where analysis of data requires in-depth evaluation of variable factors.
  8. Strong project management skills.
  9. Highly-motivated team player.
  10. Creative, innovative approach to problem solving.
  11. Attention to detail and accuracy.
  12. Excellent communication skills; ability to interact effectively with all levels in the organization..
  13. Flexible; ability to adapt to changing priorities.
  14. Some travel required (< 25%).

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