Device Development Manager
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.
- Lead or participate in new product development for INTERCEPT projects.
- 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.
- Work with Quality, Regulatory, Finance, Legal and Project management to meet project timelines and drive development and manufacturing activities to completion
- Participate on Cerus cross-functional teams and present updates from ongoing projects and timelines
- 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, 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.
- May supervise lower level engineering staff.
- 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 1971 and ISO 2859 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.
- Strong project management skills.
- Highly-motivated team player.
- Creative, innovative approach to problem solving.
- 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%).