Senior Design Quality Engineer - Medical Devices (Hybrid)

Regulatory Jobs

Pittsburgh (Allegheny County)

Hybrid

USD 90,000 - 150,000

Full time

14 days+

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Benefits offered by this job

401k Matching

Stock Options

Tuition Reimbursement

Flexible PTO

Paid Holidays

Health Insurance

HSA

Job summary

Life Unlimited. seeks a Senior Design Quality Assurance Engineer to partner with cross-functional teams and ensure quality, safety, and regulatory compliance for medical devices and software throughout the product lifecycle.

The role drives new product development and design change projects, providing leadership on software validation, verification, and regulatory compliance while mentoring teams in lifecycle best practices.

Qualifications

Master's Degree in Engineering, Computer Science, or related discipline with 4+ years of experience in quality assurance, software testing, automation, or software development
Bachelor's Degree in Engineering, Computer Science, or related discipline with 6+ years of relevant experience
Associate Degree with 8+ years of relevant experience

Responsibilities

Lead Design Quality Assurance activities for new product development and design change projects.
Complete and facilitate product risk assessments, including FMEAs and other risk management activities.
Review and approve design input requirements, specifications, and traceability documentation.
Review and approve software unit tests and support integration, verification, and validation testing activities.
Complete Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for Quality System tools.
Support audits, CAPAs, non-conformances, and compliance investigations as required.
Mentor engineering teams on software development lifecycle best practices, risk management, and design control compliance.