Biomedical Engineer
Role: Product Surveillance Analyst
Location: Burlington, MA - 01803
Duration: 08+ Months
Shift Timings: 8am to 5pm
Job Description
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
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Seniority level
Entry level -
Employment type
Contract -
Job function
Research, Analyst, and Information Technology -
Industries
Staffing and Recruiting
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