Senior Software Design Quality Engineer – Medical Devices

Boston Scientific; Arden Hills (MN); Hybrid; USD 102,000 - 194,000; Full time

Job summary

Boston Scientific Arden Hills, MN seeks a Principal Software Design Quality Engineer to lead software quality for active implantable devices. You will drive risk management, software verification/validation and cybersecurity integration across the product lifecycle.

You’ll collaborate with cross-functional teams, mentor engineers, and ensure regulatory compliance while guiding design controls and design history documentation.

Qualifications

• Bachelor’s degree in engineering, computer science or related technical discipline.
• 9+ years in design quality, software quality, or regulated medical device roles.
• Strong SDLC, risk management, and software verification / validation experience.

Responsibilities

• Lead software design quality for complex product development from concept to commercialization.
• Drive implementation of risk management per ISO 14971 with hazard analysis and software FMEAs.
• Develop and maintain software risk management tools with traceability to requirements, design, and test artifacts.
• Collaborate with cybersecurity to ensure secure product lifecycle compliance.
• Write technical documentation for development processes and regulatory evidence.
• Support post-market activities based on post-market signals.
• Participate in Design Change process to assess product changes.
• Apply validation and statistical techniques per regulatory requirements.

Skills

SDLC expertise

Risk management

Software quality tools

JIRA

Requirements & test management

Configuration management

Cross-functional leadership

Communication skills

Education

Bachelor's degree in engineering, computer science, or related technical discipline

Tools

JIRA

Version control

Requirements management platforms

Job description

Boston Scientific Arden Hills, MN seeks a Principal Software Design Quality Engineer to lead software quality for active implantable devices. You will drive risk management, software verification/validation and cybersecurity integration across the product lifecycle.

You’ll collaborate with cross-functional teams, mentor engineers, and ensure regulatory compliance while guiding design controls and design history documentation.