Senior Medical Device Quality & Compliance Engineer

Smith & Nephew; Pittsburgh (Allegheny County); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

401k Matching

Tuition Reimbursement

Discounted Stock Options

Flexible PTO

Parental Leave

Job summary

Life Unlimited. at Smith+Nephew is seeking a Senior Design Quality Assurance Engineer to partner with cross-functional teams and ensure quality and regulatory compliance of medical devices and software throughout the product lifecycle.

You will lead QA activities, perform risk assessments, review design inputs, and support CSV/CSA for quality tools while mentoring teams on best practices and regulations.

Qualifications

• Master's degree in engineering or CS with 4+ years in QA or software testing.
• Bachelor's degree with 6+ years in QA or software development; associate with 8+ years also acceptable.
• ISO 13485, ISO 14971, and IEC 62304 knowledge; FDA 21 CFR Part 820 experience.

Responsibilities

• Lead design QA activities for new product development and design change projects.
• Complete risk assessments including FMEAs and risk management activities.
• Review and approve design inputs, specifications, and traceability documentation.
• Review and approve software unit tests; support integration, verification, and validation testing.
• Complete CSV and CSA for Quality System tools.
• Support audits, CAPAs, non-conformances, and compliance investigations as required.
• Mentor engineering teams on software lifecycle best practices, risk management, and design control compliance.

Education

Master's Degree in Engineering/CS

Bachelor's Degree in Engineering/CS

Associate Degree in related field

Tools

CSV/CSA tools

Linux

Angular

React CLI

Jest

SpecFlow

Cucumber

Jasmine

JUnit

NUnit

Job description

Life Unlimited. at Smith+Nephew is seeking a Senior Design Quality Assurance Engineer to partner with cross-functional teams and ensure quality and regulatory compliance of medical devices and software throughout the product lifecycle.

You will lead QA activities, perform risk assessments, review design inputs, and support CSV/CSA for quality tools while mentoring teams on best practices and regulations.