Senior Quality Engineer - Electrophysiology - Complaint Investigation Site (CIS)

Boston Scientific•Arden Hills, MN

1d•$85,000 - $161,500•Onsite

About The Position

The Senior Quality Engineer’s primary responsibility is to monitor/trend BSC product performance within the Electrophysiology division, and when appropriate, escalate post-market field performance signals (in collaboration with cross functional teams) to mitigate risk by focusing on patient safety & driving actions to improve product performance. This position will utilize post market data to complete deep dive analysis on Electrophysiology product performance to understand if the products are performing as intended.

Requirements

Minimum of a Bachelor’s degree.
Minimum of 5 years of related experience in medical device or regulated industry.
Understanding and a command of highly technical engineering topics and applied statistics.
Understanding and experience operating within quality system processes and procedures.
Strong Technical Writing skills.

Nice To Haves

Engineering or Statistical Degree with 5+ years of relevant medical device experience.
Strong technical understanding of medical devices & the product interaction with human anatomy.
Significant participation in the Hazard Analysis and Risk Assessment as related to trend management.
Experience with the quality system escalations, CAPA investigations and field assessments.
Strong experience/understanding of the medical device regulatory requirements of post-market complaint trending and analysis.
Experience and/or previous collaboration activities with Medical Safety, Design Assurance, Complaint Investigation Site, Supplier Quality and Operations.
Ability to independently manage project work to define and consistently meet delivery dates.
Strong communication (verbal and written) and data analysis skills.

Responsibilities

Analyzing post market surveillance data for patterns and trends and investigating when necessary. May be responsible for querying & bounding data to support implementation of document releases.
Responding to Competent Authority requests and/or responsible for compiling post market data collection requests from cross-functional departments.
Owning/Completing signal evaluation forms to investigate product performance quality signals to determine if products are performing as intended by collaborating with cross-functional team members to complete risk assessment analysis and escalating further when appropriate to help drive actions to improve EP product performance.
Communicating product performance by formal presentations to management committees and design teams, supporting published product performance reports and customer requests for performance information either directly or through cross-functional departments.
Providing input for process improvement and helping develop tactical approaches to implement team strategies.
Perform data analysis for Product Performance and Risk Management documentation by applying statistical methods and software.
Owns/Leads project activities to ensure continued compliance with evolving BSC post market trending Quality Management System process requirements.
Open and flexible to change in responsibilities, taking on new engineering tasks and new product lines as the department grows and evolves.
Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
May complete and/or approve complaint investigations in accordance with local and global processes.