Device Development Manager

Location
Concord, California
Posted
Oct 02, 2020
Required Education
Bachelors Degree
Position Type
Full time

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%).