Boston Scientific Quality Engineer II 

United States, Minnesota, Arden Hills 

329711503

Your Responsibilities Will Include:

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Collaborate with technicians and manufacturing engineers in assisting in identification of manufacturing process defects, identification of primary root causes, understanding corrective and preventative actions, and dispositioning non-conforming material. May be responsible for working with process owners to bound product and document release criteria.
• Uses risk analysis tools, including but not limited to, hazard analyses, DFMEA, PFMEA, to evaluate and disposition product quality issues.
• Perform process validation and verification activities, including test method validation, and generate/review related documentation.
• Identifies possible sources of manufacturing defects and devises methods to reduce process variation to reduce/eliminate the cause of defects.
• Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
• Acts as team member in supporting quality disciplines, decisions, and practices.
• Participates in team decision making and displays team problem solving/communication skills.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Provide support and mentorship to area Quality Technicians

What we're looking for in you:

Required Qualifications

• Bachelor’s degree in engineering or science-related field
• Prior experience using non-conforming material review processes
• Basic understanding of Test Method Validation methodologies
• Minimum 2 years experience

Preferred Qualifications

• Previous experience in regulated industry, preferably medical device industry
• Familiar with the internal and external auditing process
• Proficient in Microsoft Office; Word, Excel, and Outlook
• Experience in writing, reviewing, and revising documentation
• Highly motivated and a self-starter, capable of working independently and driving projects to completion
• Capable of managing multiple projects, prioritizing, and meeting timelines
• Strong organization skills and detailed-oriented
• Must possess outstanding communication skills, both oral and written
• Ability to communicate clearly and candidly the scientific concepts and project status
• Effectively foster collaborative relationships at all organization levels
  

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.