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 includes new product development, product and quality improvements, supply chain assurance, and margin expansion projects.
- Independently design, execute, and analyze data from experiments or studies.
- Lead or participate in new product development for INTERCEPT projects.
- 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.
- Supervise engineering staff, including daily activities, deliverables, training, mentoring and performance management.
- Participate on cross-functional project teams providing contribution of ideas, developing of plans, execution of plans, and timely reporting of results.
- 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.
- Support resolution of customer complaints as needed.
- Prepare and manipulate various blood products, including plasma, platelets and RBC.
- Perform and appropriately document GLP/GMP and notebook studies.
- Author or review portions of IDEs, Regulatory Change Notifications and Design Dossiers as needed.
- Release new or revise existing documentation into the Cerus Document Control System.
- Participate in Human Resources activities such as staffing, performance management and employee development.
- Perform other related duties as required.
- Bachelors or Master’s degree in chemical, mechanical, or biomedical engineering with a minimum of 8 years’ experience.
- Supervisory experience with proven ability to mentor and guide staff.
- Must have previous experience working in a chemistry or life sciences laboratory.
- Demonstrated success working with suppliers and contract manufacturers.
- Experience working in a GMP manufacturing environment.
- Familiarity with GLP/GMP regulations & record keeping.
- Familiarity with manufacturing validation requirements (IQ/OQ/PQ).
- 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 attention to detail and accuracy.
- Flexible; ability to adapt to changing priorities.
- Excellent communication skills (verbal, written, interpersonal, listening).
- Ability to work independently and as part of a team.
- Some travel required (< 20%).