Device Development Engineer

Cerus Corporation Concord , CA 94519

Posted 3 months ago

Summary and Scope of Position:

Responsible for research, development, and ongoing hardware and software life-cycle management activities associated with devices of the INTERCEPT Blood System.

Primary Responsibilities:

  • Support design and development of new medical device technologies and solutions through prototyping, experimentation, modeling, and analysis

  • 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:
  • B.S. or higher degree in Electrical Engineering, Mechanical Engineering, Industrial Engineering, Physical Chemistry, or related engineering discipline

  • Minimum 2-5 years of relevant experience

  • Preferred practical experience in working with hardware and software subsystems on all phases of medical device, IVD, or laboratory equipment development from concept to commercialization and sustaining

  • Preferred experience working with outsourced design, development, and manufacturing partners to solve and deliver solutions to complex problems

  • Preferred experience with 21 CFR 820.30, MDD, and ISO 13485 guidelines and standards

  • Preferred experience with harmonized standards and requirements for electrical, mechanical, and software products, such as IEC 61010-1 and ISO 14971

  • Preferred experience working in a chemistry or life sciences laboratory

  • Preferred experience with HPLC, LC-MS, and other related laboratory processes and tools

  • Preferred experience with embedded, robotic, and microfluidic solution development

  • Experience in 3D modeling and drafting tools (e.g., Solidworks), and embedded systems and software (e.g., PCBA design, Altium)

  • Demonstrated problem solving skills and hands-on technical aptitude

  • Excellent verbal and written communication skills

  • 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 domestic and international travel required (< 20%)>

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Device Development Engineer

Cerus Corporation