Job Brief (Primary Responsibilities)
Lead and drive research, development, and ongoing hardware and software life-cycle management activities associated with devices of the INTERCEPT® Blood System
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company, deploying and supplying vital technologies and pathogen-protected blood components for blood centers, hospitals, and ultimately patients who rely on safe blood.
With the INTERCEPT Blood System, we are focused on protecting patients by delivering the full complement of reliable products and expertise for transfusion medicine.
Cerus develops and markets the INTERCEPT Blood System, and remains the only company in the blood transfusion space to earn both CE Mark and FDA approval for pathogen reduction of both platelet and plasma components.
Cerus currently markets and sells the INTERCEPT Blood System in the United States, Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world.
With 15+ years of routine global use, the INTERCEPT Blood System is present in >
200 Blood Centers in >
30 Countries with products sold to produce >
6,500,000 platelet and plasma units.
Our Mission To make the INTERCEPT® Blood System the standard of care in transfusion medicine.
Cerus Corporation is currently seeking a Sr. Staff Device Engineer that will lead and drive research, development, and ongoing hardware and software life-cycle management activities associated with devices of the INTERCEPT® Blood System.
The Sr. Staff Device Engineer is responsible ensuring alignment and delivery of technology solutions that meet our business objectives and the needs of our customer and patients.
Primary Responsibilities :
Lead and drive design and development of new medical device technologies and solutions through prototyping, experimentation, modeling, and analysis
Lead and support sustaining activities for commercial medical devices through technical investigations and change controls
Support manufacturing equipment development and verification (IQ / OQ / PQ) for medical device production
Support in-vitro studies and early stage clinical trials for new products
Design, setup, and conduct laboratory experiments to characterize the performance of new technical solutions and interactions with biologics and chemistry
Engage and collaborate with cross-functional teams to gather requirements, evaluate technical concepts, and contribute to technical decisions
Document, integrate, trace, analyze, and manage requirements, risks, and test protocols using appropriate management tools and processes
Plan and coordinate system integrations, verifications, and design transfers across external development teams
Provide technical guidance to project teams to accomplish tasks and achieve company objectives
Stay current with relevant developments in academia and industry through literature review and training
Prepare clear and concise technical reports and documentation in accordance with quality system requirements
Qualifications / Requirements / Skills :
Bachelor of Science or higher degree in Software, Electrical, Mechanical, Optical Engineering or equivalent
Minimum 2-5 years of relevant product development experience
Good experience throughout the product development lifecycle
Good experience with developing and sustaining embedded devices
Good leadership skills with a capability to lead distributed technical teams
Excellent problem solving skills with a preference to be hands-on
Excellent verbal and written communication skills
Preferred experience and working knowledge of medical device development, including a thorough understanding of and familiarity with 21 CFR 820.
30, MDD, and ISO 13485 guidelines and standards
Results driven and highly motivated self-starter that can work independently with minimal supervision
Flexible with the ability to manage simultaneous tasks and adapt to changing priorities
Some travel required (