Device Development Engineer

94520, Concord
Dec 07, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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


  • 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

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