Senior Quality Engineer

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 ranked #2 among medical device companies on Forbes America's Best Places to Work for Engineers 2026. Whether your passion lies in systems, software, human factors, or beyond, this is a place where you can grow your career and be part of something bigger—advancing science for life.

We are seeking a quality-focused professional to drive key initiatives in sustaining product support, quality investigations, process improvements, and new product introductions. In this role, you will serve as a technical leader supporting manufacturing and engineering teams, ensuring compliance with rigorous industry standards while advancing patient safety and product quality.

 

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office. 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:

● Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

● Collaborate with technicians and manufacturing engineers to identify manufacturing process defects, determine primary root causes, evaluate corrective and preventive actions, and disposition non-conforming material.

● May be responsible for defining product boundaries and establishing document release criteria.

● Use risk analysis tools—including but not limited to hazard analyses, DFMEA, and PFMEA—to evaluate and disposition product quality issues.

● Support process validation and verification activities, including test method validation, and generate/review related documentation.

● Identify potential sources of manufacturing defects and devise methods to reduce process variation and eliminate defects.

● Lead process improvement efforts by identifying methods to capture quality metric data and applying appropriate analysis techniques to enhance sustaining and new product development.

● Act as a team member in supporting quality disciplines, decisions, and practices.

● Participate in team decision making and demonstrate strong problem-solving and communication skills.

● Partner with Project Management and cross-functional teams to support new or updated products entering the manufacturing area.

● Provide process ownership and Material Review Board (MRB) support.

● Proactively investigate, identify, and implement best-in-class quality engineering practices.

● Mentor and support area Quality Technicians.

● Perform Device History Record (DHR) review and Final Product Release activities.

● Monitor and ensure compliance to internal quality systems and external industry regulations.

● Perform other duties as assigned.

 

Qualifications:

Required qualifications:
● Bachelor’s degree in a scientific or engineering discipline, or equivalent combination of education and experience.

● Minimum of 2 years' experience (Quality Systems Engineer II) or minimum of 5 years' experience (Senior Quality Systems Engineer) in a pharmaceutical, medical device, or other highly regulated industry.

● Experience in capital equipment design and production or with similar medical devices while working within a Quality function.

● GMP experience within ISO 13485 and FDA 21 CFR Part 820 environments.

● Experience in risk analysis methodologies.

● Strong analytical, planning, and organizational skills.

● Strong interpersonal and communication skills (oral and written).

● Self-starter with ability to work independently under pressure and adapt to changing priorities.

● Proficient in MS Office (Word, Excel, PowerPoint, Project, Visio).

Preferred qualifications:
● Experience performing test method validation and Gage R&R studies.

● In-depth understanding of statistical techniques such as normality analysis and tolerance analysis, with demonstrated ability to analy