Device Engineer

2 weeks ago

Concord, United States Cerus Corporation Full time

About Cerus:

Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.

Primary Responsibilities:
  • Lead and support design and development of new medical device technologies and solutions
  • Lead and support design transfer, manufacturing and sustaining activities for commercial medical devices
  • Engage and collaborate with cross-functional teams to gather and define product requirements, define high-level design, evaluate technical concepts, and contribute to technical decisions
  • Act as a systems and software subject matter expert to provide technical guidance to project teams that accomplishes tasks and achieves company objectives
  • Plan and coordinate detailed design, implementation, verification, and design transfer across external development teams and vendors
  • Design, setup, and conduct laboratory experiments to characterize the performance of new technical solutions and interactions with biologics and chemistry
  • Support in-vitro studies and early-stage clinical trials for new products
  • Define and maintain medical device software lifecycle processes and instructions per IEC 62304
  • Define and maintain a software development environment and supporting tools
  • Prepare clear and concise technical reports and documentation in accordance with quality system requirements
  • Stay current with relevant developments in academia and industry through literature review and training
Qualifications/Requirements/Skills:
  • Bachelor of Science or higher degree in Computer Science, Computer Engineering, Electrical Engineering, or similar
  • Minimum 5 years of relevant product development experience, including software development and testing experience per IEC 62304
  • 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 Part 820, EU MDR, and ISO 13485 guidelines and standards
  • Preferred experience and working knowledge of Cybersecurity guidance and best practices
  • Preferred experience in software design and implementation in relevant programming languages (e.g., C, C++, C#, Python)
  • 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 (

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