Job Brief (Primary Responsibilities)
Responsible for development and manufacturing support for the INTERCEPT technology platform
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).
Qualifications / Requirements / Skills :
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 (