Senior Design Quality Engineer — Hybrid Medical Devices

Boston Scientific Gruppe; Maple Grove (MN); Hybrid; USD 89,000 - 170,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Boston Scientific is hiring a Senior Design Quality Engineer for Bolt Integration at the Arbor Lakes Campus in Maple Grove, MN. The role requires collaboration across R&D, manufacturing, supplier and regulatory functions to protect design intent and ensure safety and compliance.

On-site presence is required at least three days per week, with relocation assistance possibly available. The position emphasizes quality processes, CAPA ownership, risk management, and Design Controls across cross-site

Qualifications

• Bachelor's degree in engineering or related field with 5+ years in medical device quality
• Knowledge of US and international regulations including 21 CFR 820 and ISO 13485/14971
• Experience applying quality tools and methodologies in design assurance and product development
• Ability to collaborate across sites and functions

Responsibilities

• Lead or participate as a team member in quality disciplines and decisions
• Apply quality engineering principles to products and sites
• Provide coaching and mentoring to engineers and technicians
• Advise on improvements to quality systems and processes
• Support and guide team members in quality activities
• Implement best-in-class Design Quality Engineering practices
• Participate in Design Change processes and risk management
• Collaborate with R&D, manufacturing, and supplier teams on Design Controls
• Use systematic problem-solving to address quality issues and CAPA ownership
• Monitor field performance and risk assessments for launched devices
• Contribute to Risk Change assessments and maintain risk tools
• Support verification, validation, and usability testing
• Align software changes with system-level design impact assessments
• Develop and maintain Design History File documentation

Skills

Quality engineering

Cross-site collaboration

Leadership

Regulatory knowledge

Education

Bachelor’s degree in engineering or related field

Tools

FMEA

Quality tools

Job description

Boston Scientific is hiring a Senior Design Quality Engineer for Bolt Integration at the Arbor Lakes Campus in Maple Grove, MN. The role requires collaboration across R&D, manufacturing, supplier and regulatory functions to protect design intent and ensure safety and compliance.

On-site presence is required at least three days per week, with relocation assistance possibly available. The position emphasizes quality processes, CAPA ownership, risk management, and Design Controls across cross-site