Demo

Device Engineer - Software

Proclinical
Concord, MN Full Time
POSTED ON 4/6/2025
AVAILABLE BEFORE 5/5/2025

Device Engineer - Software - Permanent - Concord, CA

Proclinical is partnered with a medical device organization that needs to expand its engineering capabilities in efforts to product new therapeutics products. Skills & Requirements :

  • 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 and 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 (

The Device Engineer will :

  • 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
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