Device Development Engineer

Location
94520, Concord
Posted
Dec 07, 2018
Discipline
Engineering
Hotbed
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

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

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