Quality Engineer II

Boston Scientific•Maple Grove, MN

1d•$71,500 - $135,800•Onsite

About The Position

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About This Role: Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support. This role will support the Core Tech Polymer team within Maple Grove Operations. At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office five days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Requirements

Bachelor’s degree in engineering or science related field
Minimum 2 years experience in an engineering or science related field

Nice To Haves

Experience in a regulated medical device industry, preferably in Quality
Experience in an operations setting
Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering
Prior experience with non-conforming material review process
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.).
Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards

Responsibilities

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 to bound product and document release criteria.
Uses risk analysis tools, including but not limited to, hazard analyses, DFMEA, PRA, 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.
Working with Project Management and Division teams to support new and updated products added to the area
Process ownership
Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
Provide support and mentorship to area Quality Technicians