Senior Quality Software Engineer - Regulated Med Devices

Lancesoft; Austin (TX); Remote; USD 110,000 - 170,000; Full time

Job summary

Client in the medical device sector seeks a Sr Quality Software Engineer with expertise in software validation and quality, capable of supporting FDA, IEC and ISO standards. The role is remote with travel to Austin, TX; onsite five days a week in Austin during travel windows.

The ideal candidate will perform validation planning, execution, and reporting, maintain compliance documentation, and collaborate with R&D, QA and Regulatory teams to ensure product quality across embedded and cloud-based

Qualifications

• Bachelor's degree in a related field with 4 years of relevant experience, or equivalent.
• Experience in regulated medical device environments (FDA/IEC/ISO).
• Ability to perform software validation and quality activities across software lifecycle.

Responsibilities

• Perform software quality review of requirements, design, and deliverables for FDA/ISO/IEC compliance.
• Develop and execute validation tests, test plans, and RTMs.
• Support audit readiness and regulatory inspections (FDA, ISO).
• Collaborate with cross-functional teams (R&D, QA, Regulatory).
• Participate in risk assessments and design/code reviews.

Skills

V&V principles

Regulatory compliance

RTM

Test planning

Risk assessment

Design reviews

Regulatory standards

Education

Bachelor's Degree

Job description

Client in the medical device sector seeks a Sr Quality Software Engineer with expertise in software validation and quality, capable of supporting FDA, IEC and ISO standards. The role is remote with travel to Austin, TX; onsite five days a week in Austin during travel windows.

The ideal candidate will perform validation planning, execution, and reporting, maintain compliance documentation, and collaborate with R&D, QA and Regulatory teams to ensure product quality across embedded and cloud-based