Quality Engineer II

Boston ScientificArden Hills, MN
$71,500 - $135,800Hybrid

About The Position

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.

Requirements

  • 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.

Nice To Haves

  • 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.

Responsibilities

  • 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.

Benefits

  • 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).
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