Intellectt Inc

Biomedical Engineer

Intellectt Inc Burlington, MA

Role: Product Surveillance Analyst

Location: Burlington, MA - 01803

Duration: 08+ Months

Shift Timings: 8am to 5pm

Job Description

  • Years Experience: 0 - 2 years
  • Skills: Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred.
  • Education: Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis.
  • Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.
  • Duties: May perform multiple functions within the post market surveillance department.
  • Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality.
  • Complete FDA MDR and other outside competent authority regulatory reports.
  • Will accept fresh college graduates with internship or capstone project work
  • Someone with a Biomedical degree would be a good fit as this will allow for future opportunities
  • Manager is open to someone with a background and/or degree in Technology or the Sciences
  • If person has 0 - 2 years of course work or work experience they will be considered
  • Person will be in-front of a computer for the entire day and will be successful if they can manage their time effectively and efficiently - must have organizational skills.
  • Will be working with a complex product which is a heart pump in managing the day-to-day events and qualitative data related to product and patient information coming in from the field
  • Must have excellent communication, organizational, attention to detail, and time management skills;
  • Will be using MS office suite with basic Excel working knowledge
  • A person that has juggled a job and school or a sport and school is a good candidate
  • There will be a first round of interviews which will be a 20 minute phone screen to assess for fit and culture; followed by a second round of an in-person interview for 30 minutes with the HM and 30 minutes with another group
  • Seniority level

    Entry level
  • Employment type

    Contract
  • Job function

    Research, Analyst, and Information Technology
  • Industries

    Staffing and Recruiting

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