Boston Scientific Quality Engineer II 

United States, Minnesota, Arden Hills 

150773362

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 you

Required qualifications:

• Bachelor’s degree in engineering or science related field
• Experience in a regulated medical device industry
• Prior experience with non-conforming material review process
• Basic understanding of test method validation methodologies
• Minimum 2 years experience

Preferred qualifications:

• Experience in molding and silicone related materials
• Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering
• Experience in Validation, Statistical sampling and/or Root Cause Investigation
• Familiarity with product documentation, inspection and testing, and Manufacturing Execution
• Problem Solving Certification (Green Belt, CQE, Six Sigma, etc.).
  

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.