Boston Scientific Senior Service Quality Engineer 

United States, Minnesota 

664376097

About the role:The Senior Service Quality Engineer is a subject-matter expert in service quality for Boston Scientific’s Medical Electrical Equipment/ Capital Equipment (CE) products. This position provides leadership in developing, executing, and continuously improving product related service quality requirements, ensuring that service and installation processes meet global regulatory requirements and deliver exceptional customer outcomes. The role bridges product design and field service, ensuring that service performance and feedback directly inform product improvement, risk management, and reliability engineering.

The Service Quality Engineer operates with minimal supervision, leads cross-functional initiatives, mentors peers, and influences the strategic direction of service quality within the organization.

Your responsibilities will include:

• Lead integration of service requirements into new-product design and risk-management processes.
• Serve as the service-quality owner for assigned products, ensuring alignment between DHF, DMR, and field-service documentation.
• Evaluate complex product or process changes for quality and risk impact; ensure all risk controls remain effective.
• Champion continuous improvement of product reliability through analysis of field performance data, and service metrics.
• Establish robust systems to ensure accurate Service History Record capture and traceability via Service Management and SAP systems.
• Represent service quality in design reviews, risk assessments, and post-market monitoring.

Process Focus

• Drive enhancement and standardization of CE-related Service Quality System elements: Design Controls, Risk Management, CAPA/NCEP, Installation & Servicing Controls.
• Lead significant CAPA/NCEP investigations, ensuring strong root-cause analysis and sustainable corrective actions.
• Partner with global and regional teams to implement best practices for service quality metrics and reliability measurement.
• Lead Service quality-system integration for acquisitions, assessing gaps, developing integration plans, and mentoring local quality teams.
• Monitor key process indicators for CE service performance, influencing operational and business decisions.
• Collaborate with upstream engineering to implement systemic improvements that reduce service-related nonconformances.

People & Culture Focus

• Serve as a role model of BSC’s quality and compliance culture.
• Provide mentorship and technical guidance to junior team members and cross-functional partners.
• Influence leadership teams by presenting balanced risk-based rationales that protect patients while enabling business agility.
• Foster collaboration across Service Development Engineering, Service QA, NPE Project Management, Field Service, and Global teams.
• Promote a culture of curiosity, accountability, and high performance.
• Lead VIPs and continuous-improvement initiatives that drive measurable efficiency gains.
• Encourage a “Yes – and here’s how” mindset to support business enablement while maintaining compliance.

Required qualifications:

• Bachelor’s degree in a technical field
• Minimum of 6 years of related work experience including relevant experience in the Medical Device industry
• Working knowledge of relevant standards and regulations such as 21CFR820, IEC60601, IEC 62353, ISO 13485.

Preferred qualifications:

• Masters degree in engineering
• Experience working with medical electrical equipment
• ASQ Certification in Six-Sigma Green Belt and/or Quality disciplines
• Experience working with BSC Quality System

The anticipated annualized base amount or range for this full time position will be$ to $, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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.

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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.