Entry-Level Post-market Surveillance Engineer positions

ChBE alumna Brittany Michael sent the following job announcement.

My direct client, one of Boston's top medical device companies in Boston, MA is hiring a Post-market Surveillance Engineer for their post-market team.

This fast-paced, cross-functional position is the perfect opportunity for bright, entry-level or young professional candidates with a Bachelor's in Biomedical Engineering to grow and learn while supporting a blood analyzer device.

This role is not recommended for candidates seeking a career in R&D.

Location: Boston, MA (training fully onsite 1-2 months, after that hybrid 4 days/week onsite)

Duration: Contract-to-hire with full-time headcount approved

The Postmarket Engineer is responsible for pulling data to support trending of product complaints and medical device reports utilizing data that resides in the complaint handling database for all product lines. This will include detailed data reports (e.g. graphs, charts, tables) prepared for routine trending, senior management reviews, ad-hoc requests, and cross-functional requests as needed (e.g. Regulatory, Quality Engineering, R&D). The Postmarket Engineer will establish and maintain complex reporting formulas and templates using reporting tools such as Excel and other databases (e.g. Business Objects).

Note: new position Initiates and manages the complaint file, maintains accurate entry of complaints in the database, communicates to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g. FDA, ECA) and submits reports within required timeframe, diligent of any unusual trends in product complaints and communicates them with mgmt., complies with US FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments, Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors. Performs other related duties and responsibilities as assigned.

Four-year degree in Biomedical Engineering is required. Additional professional or internship/co-op experience in medical devices, particularly involving complaint handling investigations, medical device reporting, or product analysis is a huge plus.