Quality Engineer II
Arden Hills, MN, US, 55112
Additional Location(s): N/A
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.
Boston Scientific was 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.
As a Quality Engineer II, you will investigate product complaints and monitor product performance to help ensure Boston Scientific products continue to meet the highest standards of quality, safety and effectiveness. Using post-market surveillance data, complaint investigations and advanced data analysis, the incumbent will identify trends, evaluate field performance signals and collaborate with cross-functional teams to better understand product performance, mitigate risk and improve patient outcomes. This role offers the opportunity to make a meaningful impact by supporting product quality and patient safety across the product life cycle.
Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office Arden Hills, MN at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Your responsibilities will include:
● Review completed returned product analyses, customer feedback and historical data to accurately code product complaints.
● Perform complaint investigations in accordance with local and global quality system requirements.
● Analyze post-market surveillance data to identify patterns, trends and potential product performance signals, initiating investigations as appropriate.
● Query, analyze and bound data to support document releases and product performance assessments, as needed.
● Respond to Competent Authority requests with accurate and timely technical information.
● Communicate product performance through formal presentations to management committees and design teams, published product performance reports and customer performance requests in partnership with the sales organization.
● Support continuous process improvement initiatives and contribute to the development and execution of team strategies.
● Perform statistical analyses to support Product Performance and Risk Management documentation using appropriate analytical methods and software.
● Lead or support cross-functional projects by developing project plans, defining timelines, coordinating resources and driving execution.
● Demonstrate flexibility by supporting new engineering initiatives, products and evolving departmental priorities.
Required qualifications:
● Minimum Bachelor's degree in Engineering or a related technical discipline.
● Minimum of 2 years' experience in a quality engineering, product performance or related engineering role.
● Strong desire about solving complex problems, improving patient outcomes, and contributing to a collaborative team.
● Demonstrated understanding of engineering principles, technical concepts and applied statistics.
● Ability to independently manage multiple priorities and consistently deliver results within established timelines.
● Experience working within regulated quality systems, processes and procedures.
● Strong written and verbal communication skills with the ability to effectively analyze and present technical data.
Preferred qualifications:
● Engineering degree with minimum of 4 years' experience in the medical device industry.
● Strong technical understanding of medical device therapies and products.
● Experience participating in Hazard Analysis and Risk Assessment activities related to product trend management.
● Experience supporting quality system escalations, CAPA investigations and field assessments.
● Working knowledge of global medical device regulatory requirements related to post-market complaint handling, trending and analysis.
● Experience collaborating with Medical Safety, Design Assurance, Returned Product Analysis, Supplier Quality and Manufacturing teams.
● Experience applying statistical methods and data analytics to support product performance monitoring and risk management.
● Demonstrated ability to work effectively across cross-functional teams while driving continuous improvement initiatives.
Requisition ID: 631218
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.
Nearest Major Market: Minneapolis
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Medical Device Engineer, Testing, Quality Engineer, Medical Device, Manufacturing Engineer, Engineering, Technology, Healthcare