Quality Engineer II
Quality Assurance
Sacramento, CA, USA · arden hills, mn, usa
USD 71,500-135,800 / year
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. Here, you’ll be supported in progressing – whatever your ambitions.
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.
Requisition ID: 633816
Minimum Salary: $ 71500
Maximum Salary: $ 135800
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.