Device Development Manager
Provides engineering and laboratory support for the Class III INTERCEPT Blood System for Platelets, Plasma, and Red Blood Cells. This position is focused primarily on the single-use INTERCEPT Processing Sets and components thereof. The scope of this position will include new product development, product and quality improvements, supply chain assurance and life cycle improvement.
Lead meetings and interactions with suppliers, contract manufacturers, and external testing laboratories. Assist suppliers and/or contract manufacturers in problem solving with respect to components, processes, and test methods. Independently design, execute, and analyze data from experiments or studies. Participate in product improvement and ongoing supply assurance/cost savings projects for commercial INTERCEPT products. Define and execute studies and validation plans, including both hands-on laboratory experiments and manufacturing studies. Work with external suppliers and contract manufacturers to meet project timelines and drive development and manufacturing activities to completion. Note trends and aberrations in data, identify problems and suggest/conduct experiments to determine root cause and develop solutions. Reduce and analyze highly complex data and present it to maximize clarity and impact. Participate on cross-functional project teams providing contribution of ideas, developing of plans, execution of plans, and timely reporting of results. Release new or revise existing documentation into the Cerus Document Control System. Create Cerus specifications for raw materials, components, and finished goods. 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. Fabricate or procure prototype components for development testing for next gen RBC system, 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. Author or review portions of IDEs, Regulatory Change Notifications, and/or Design Dossiers, as needed. 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 Qualifications/Requirements/Skills:
Bachelors or master’s degree in chemical, mechanical, or biomedical engineering with minimum 8 years of medical device/IVD disposables development experience. Supervisory experience with ability to mentor and guide lower-level engineers. Demonstrated success in working with suppliers and contract manufacturers. Knowledge of QSR, ISO 13485, ISO 10993, ISO 14971 requirements for medical devices. Knowledge of GMP requirements for single-use medical device, including validation, testing, and sterilization requirements. Expertise in flexible plastic containers, injection-molded components, and packaging systems. Ability to work on complex issues where analysis of data requires in-depth evaluation of variable factors. Proficient in writing protocols and reports. Ability to make decisions on the validity and importance of experimental results, the potential success or failure of activities within their area of expertise. Excellent mathematical skills, problem solving skills, and ability to apply scientific methods to resolution. Solid experience with related computer software. Strong project management skills and highly motivated team player. Creative, innovative approach to problem solving. Strong attention to detail and accuracy. Excellent communication skills: ability to interact effectively with all levels in the organization. Flexible; ability to adapt to changing priorities. Some travel required (< 25%). All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.