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Systems Engineer

The Role:  We are looking for a Systems Engineer with a software and hardware background to become a member of a rapidly growing team with a mix of engineers and biologists in our product development team for cell therapy manufacturing equipment. You are responsible for designing, defining, updating, and implementing system requirements, system specifications, input/output processes and working parameters by using current systems engineering methods and technologies. You analyze and coordinate system partitioning (i.e. hardware/software partitioning) and total system integration by using systems engineering practices. You provide expertise and conducts evaluation, validation and verification activities. You document system requirements according to approved procedures and standards. You assist with industry based standards testing for software. You utilize appropriate simulation and analysis tools. You work to ensure efficient and effective transfer of product into production. The candidate must have a desire to utilize their skills to solve complex technical problems in a hands-on manner, working in a fast-paced environment, and across multiple internal and external stakeholders and SMEs. 

 

Who You Are:

  • Degree in Systems, Biomedical, Software or equivalent engineering field: Bachelors with 10 years’ experience; Masters with 8 years’ experience; PhD with 5 years’ experience.
  • Excellent core engineering skills and relevant industry experience.
  • Experience performing multi-discipline, systems-level engineering development.
  • Expertise in common engineering development tools for software development and mixed hardware and software systems.
  • Experience with Life Sciences industry and with existing regulation (e.g. 21CFR part 11) and validation guidelines (e.g. GAMP5) is preferred; computer validation practices (e.g. CSV) is a plus.
  • Familiarity with FDA and EMA requirements for manufacturing equipment and software.
  • Strong communications and time management abilities.
  • Ability to manage multiple tasks/projects.
  • Experience working with CDMOs for research and manufacturing.
Job Requisition ID:  179392
Location:  Bedford
Career Level:  E - Professional (10+ years)
Working time model:  full-time


Job Segment: Product Development, Testing, Research, Technology

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