Quality Engineer II

Quality Engineer II

Work mode:
Onsite Onsite Location(s):
Arden Hills, MN, US, 55112 Additional Location(s): US-MN-Arden Hills Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance 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.

About the role:

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. The company was also recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. This Quality Engineer II role provides quality engineering support for CDx production operations at our Arden Hills, Minnesota, site.

In this role, you will help ensure the delivery of high-quality results to customers while supporting continuous improvement projects and quality initiatives. You will partner with a broader cross-functional team to provide day-to-day manufacturing floor support, proactively solve problems, support nonconformance (NC) dispositions, and contribute to nonconforming event and process (NCEP) and corrective and preventive action (CAPA) activities. You will also support value improvement projects and Workstation Vulnerability Assessment efforts.

In this fast-paced, dynamic environment, you will serve as a process owner for assigned manufacturing lines and work cross-functionally with manufacturing engineering and production partners to achieve business goals while maintaining a strong focus on quality. Work model, sponsorship:
This role follows an on-site work model and is based at our Arden Hills, Minnesota, location. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include:
Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues. Collaborate with technicians and manufacturing engineers to identify manufacturing process defects, determine primary root causes, develop corrective and preventive actions, and disposition nonconforming material. Support product containment activities and establish appropriate product and document release criteria. Use risk analysis tools, including hazard analyses, design failure mode and effects analysis (DFMEA) and probabilistic risk assessment (PRA), to evaluate and disposition product quality issues.

Perform process validation and verification activities, including test method validation, and generate or review related documentation. Identify potential sources of manufacturing defects and develop methods to reduce process variation and eliminate or mitigate the causes of defects. Lead process improvement efforts by identifying methods to capture quality metrics and performing appropriate analyses to support sustaining product design and new product development.

Support quality disciplines, decisions and practices as an active member of cross-functional teams. Participate in team decision-making and demonstrate effective problem-solving and communication skills. Partner with Project Management and divisional teams to support new and updated products introduced into the manufacturing area. Collaborate with IT teams to develop and implement updates to manufacturing systems. Serve as a process owner for assigned manufacturing processes and lines.

Proactively investigate, identify and implement best-in-class quality engineering practices. Provide support and mentorship to quality technicians.

Qualifications:

Required qualifications:

Bachelor's degree in engineering, science or a related field. Minimum of 2 years' experience in an engineering- or science-related field, or an equivalent combination of education and experience.

Preferred qualifications:

Experience in the regulated medical device industry, preferably in quality. Experience working in a manufacturing or operations environment. Experience in finished goods manufacturing. Experience collaborating with functions such as manufacturing engineering, post-market complaints, CAPA, risk management, supplier quality and process engineering. Experience with nonconforming material review processes. Experience with validation, statistical sampling and/or root cause investigation. Familiarity with product documentation, inspection and testing, and manufacturing execution systems.

Problem-solving certification, such as Green Belt, Certified Quality Engineer (CQE) or Six Sigma. Knowledge of Quality System Regulations, Medical Device Regulation and ISO 13485 quality standards. The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific…