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.  

Primary Responsibilities:

• 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. 

  Qualifications/Requirements/Skills: 

• 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%).