Insulet Corporation Post Market Associate Engineer in Billerica, Massachusetts

This position is an integral part of Insulet’s Quality Department. This role requires strong organization skills and attention to detail while working with other Quality functions to ensure compliance and the accomplishment of departmental and company goals. This is a hands-on engineering role conducting post market investigations of FDA approved medical devices.

  • Perform moderately complex tasks to ensure compliance with quality standards.

  • Work with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained.

  • Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA.

  • Perform product testing and failure analysis.

  • Review and track Lot Acceptance records and DHRs, create trend charts.

  • Perform data logging of quality data and trend results. Gather data where needed. This involves consistent follow up and expediting actions.

  • Assist in gathering information during FDA and ISO 13485 inspections.

  • Trouble shoot new failure modes.

  • Evaluate process flow accompanied by applying lean thinking to streamline.

  • Perform deep dive investigations to develop hypothesis for failure

  • Evaluate fixturing to help improve safety and efficiency

  • Perform other duties as assigned.

  • BS in engineering, a technical, or scientific discipline; or AS in the same disciplines with equivalent work experience. Electrical and mechanical background strongly preferred. Knowledge of electronics.

  • Computer proficiency in MS office (specifically Excel); experience creating and analyzing charts and Pareto charts a plus. Knowledge of Six Sigma, Lean, SPC and/or ISO process controls a plus.

  • Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred.

  • Minimum of 2 years in a Quality related function working with QSR and/or ISO 13485 preferred.

Skills and Competencies

  • Effective verbal and excellent technical writing skills

  • Ability to communicate and work effectively within and across the organization.

  • Ability to organize and follow through with tasks with minimal supervision.

  • Excels at generating and maintaining organized and accurate records.

External Company Name: Insulet Corporation

External Company URL: http://www.myomnipod.com/