Regulatory/Biomedical Engineer

Role: Product Surveillance AnalystLocation: Burlington, MA 01803Duration: 12+ MonthsShift Timings: 9 AM to 5 PM100% Onsite role.

Skills Looking For:Entry-level position, but some relevant experience or exposure to regulatory affairs is beneficial.The project involves post-market surveillance, focusing on qualitative data related to patient experiences with medical devices, specifically the Heartmate pump.It is a computer-based role, with no hands-on involvement with the product.Strong time management, organizational skills, and ability to manage priorities effectively.Basic knowledge of Microsoft Office software.Background in STEM fields preferred, particularly biomedical engineering.Basic proficiency in Microsoft Office software is required.Day-to-day Responsibilities: Analyzing qualitative data regarding patient experiences with medical devices; Making decisions based on FDA regulations and international regulations; Collaborating with healthcare professionals, engineers, and field coordinators; Managing conflicting priorities and effectively communicating with team members.Education and Level of Experience:Bachelor's degree is required, preferably in STEM fields such as biomedical engineering.Entry level role (0 to 2 years of experience).Fresh graduate: Academic Achievements, Internships or Volunteer Work, Extracurricular activities during course work.Top 3 Skills:Strong time management and organizational skills.Ability to manage priorities effectively in a fast-paced environment.Basic proficiency in Microsoft Office software.