Boston Scientific Quality Engineer - Post-Market Assurance 

United States, Minnesota, Arden Hills 

404443719

Your responsibilities will include:

• Analyzing customer complaints, events, and other post-market surveillance data by examining the data for patterns and trends and investigating when necessary
• Conducting product signal escalation analysis, investigation, and quality system documentation to identify performance improvement opportunities; may include NCEP & CAPA ownership
• Mentoring product investigators by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques; grow team utilization of investigative equipment (X-Ray, FTIR, SEM, etc.)
• Partnering with cross-functional teams to ensure the development and execution of streamlined, robust solutions to CIS processes are effectively implemented while still meeting organizational and regulatory requirements
• Communicating product performance by formal presentations to management committees and design teams, supporting published product performance reports, and supporting customer requests for performance information either directly or through the sales organization
• Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Post-Market organizations
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Required qualifications

• Bachelor's degree in engineering, or Bachelor’s degree in another related technical/scientific discipline with relevant experience (experience could include internships or co-ops)

Preferred qualifications

• Bachelor’s degree in engineering
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards
• Experience in Medical Device industry or a Quality organization
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Ability to collaborate and influence across multiple, cross-functional teams
• Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis
• Self-starter with the ability to identify improvement opportunities

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.