Quality Engineer III - Defined Term

Boston Scientific; Arden Hills (MN); Hybrid; USD 78,000 - 149,000; Full time

Job summary

Boston Scientific is seeking a Quality Engineer III - Defined Term in Minnesota to monitor, investigate, and escalate product performance signals across the Neuromodulation post-market team. This 18-month role collaborates with Design Assurance, R&D, and manufacturing to drive improvements and ensure patient safety.

The ideal candidate has a statistics/engineering background, 3+ years in medical device quality, and experience in FDA/ISO quality systems.

Qualifications

• Bachelor's degree in Statistics, Engineering, Life Sciences, Biomedical Sciences, or related technical discipline.
• Minimum of three (3) years of professional engineering experience in medical device quality engineering, manufacturing quality, supplier quality, post-market quality, reliability engineering, or related technical role.
• Experience working within FDA and/or ISO-regulated quality systems.
• Experience conducting quality investigations and applying statistical or data-driven methods to support quality, risk management, compliance, or product performance decisions.
• Experience utilizing electronic Quality Management Systems (eQMS) such as TrackWise, Windchill, SAP, PLM, or equivalent systems.

Responsibilities

• Perform complaint monitoring, statistical trending, and signal evaluation activities to identify emerging product quality and patient safety concerns.
• Conduct signal assessments and present findings, recommendations, and escalations to management review boards and cross-functional stakeholders.
• Develop, maintain, and improve complaint monitors aligned with risk management documentation, product hazards, and surveillance requirements.
• Execute ad hoc data analyses to support Quality, Regulatory, Clinical, Engineering, and business partner requests.
• Apply statistical methodologies and Statistical Process Control (SPC) techniques to evaluate product performance and identify meaningful trends.
• Collaborate with Risk Management teams to ensure surveillance activities remain aligned with product risks and evolving post-market requirements.
• Investigate data anomalies and develop recommendations to improve data quality, monitoring effectiveness, and signal detection capabilities.
• Communicate analytical findings to both technical and non-technical audiences through clear visualizations, presentations, and written summaries.
• Support audit readiness and compliance with applicable quality system and regulatory requirements.

Skills

Statistical methods

Quality investigations

Post-market surveillance

FDA/ISO quality systems

Education

Bachelor's degree in Statistics, Engineering, Life Sciences, Biomedical Sciences, or related discipline

Tools

TrackWise

Windchill

SAP

PLM

Job description

Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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:Please note that this is a defined-term position of up to 18 months. Defined-term employees are eligible for most benefits, including paid vacation, 401K matching, and healthcare benefits.Join the Neuromodulation post-market complaint trending team as a Quality Engineer III - Defined Term, where we are committed to transforming customer experiences into actionable insights that improve patient outcomes across the globe. In this role, you will be responsible for monitoring, identifying, investigating, and escalating product performance signals related to our products within the Neuromodulation division. This is an exciting opportunity within the Post Market Organization to collaborate with Design Assurance, R&D, Supplier Engineering, and Manufacturing teams to ensure a comprehensive understanding of product performance and to drive continuous improvement.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 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.At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office at least three (3) 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.Your responsibilities will include:Perform complaint monitoring, statistical trending, and signal evaluation activities to identify emerging product quality and patient safety concernsConduct signal assessments and present findings, recommendations, and escalations to management review boards and cross-functional stakeholdersDevelop, maintain, and improve complaint monitors aligned with risk management documentation, product hazards, and surveillance requirementsExecute ad hoc data analyses to support Quality, Regulatory, Clinical, Engineering, and business partner requestsApply statistical methodologies and Statistical Process Control (SPC) techniques to evaluate product performance and identify meaningful trendsCollaborate with Risk Management teams to ensure surveillance activities remain aligned with product risks and evolving post-market requirementsInvestigate data anomalies and develop recommendations to improve data quality, monitoring effectiveness, and signal detection capabilitiesCommunicate analytical findings to both technical and non-technical audiences through clear visualizations, presentations, and written summariesSupport audit readiness and compliance with applicable quality system and regulatory requirementsRequired qualifications:Bachelor's degree in Statistics, Engineering, Life Sciences, Biomedical Sciences, or related technical disciplineMinimum of three (3) years of professional engineering experience in medical device quality engineering, manufacturing quality, supplier quality, post-market quality, reliability engineering, or related technical roleExperience working within FDA and/or ISO-regulated quality systemsExperience conducting quality investigations and applying statistical or data-driven methods to support quality, risk management, compliance, or product performance decisionsExperience utilizing electronic Quality Management Systems (eQMS) such as TrackWise, Windchill, SAP, PLM, or equivalent systemsAbility and willingness to work in a defined-term role for up to 18 monthsPreferred qualifications:Complaint trending, post-market surveillance, or signal detection experienceExperience with Power BI, Tableau, Spotfire, or similar analytical toolsExperience presenting trend analyses or quality metrics to stakeholdersExperience with risk management methodologies such as FMEA or risk assessmentsStrong written and verbal communication skills, both technical and conversationalEffective decision-making and negotiation skills, both independently and in team settingsExperience managing multiple projects across different functional areasRequisition ID: 635605Minimum Salary: $ 78300Maximum Salary: $ 148800The 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.