Senior Software Quality Engineer

LivaNova

Quality Engineer ensuring compliance and risk management in medical device software development. Providing leadership, technical direction, and contributing to regulatory audits in a medtech company.

Posted 5/27/2026full-timeHouston • Texas • 🇺🇸 United StatesSenior💰 $130,000 - $150,000 per yearWebsite

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

Serves as a core team member on software/firmware product development teams by providing technical leadership and direction.
Responsible for the risk management file, compliance with design control regulations, development of design requirements, architecture specifications, and design verification/validation.
Chair the change control board within projects for change requests and defects identified during the course of development.
Lead investigations of software/firmware related complaints, defects identified during development, or from manufacturing nonconformities, audit responses and CAPAs.
Generates, maintains and updates risk management documentation throughout the life cycle of a product.
Leads the post-market cybersecurity process by monitoring potential threats and initiating further review and analysis with security experts.
Ensures compliance with software / firmware development and non-product software validation procedures.
Contributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter expert.

Requirements

What you’ll need

BS in Computer Engineering / Computer Science / Electrical Engineering (with education/experience in software development) preferred
Experience with developing software or firmware in the medical device industry including demonstrated proficiency in meeting the requirements of IEC 62304.
Develop and maintain strong, positive business relationships with key internal customers such as R&D, Clinical, Regulatory Affairs, and Operations.
Maintain and improve technical knowledge in software/firmware development and test.
Possesses in depth knowledge of pertinent regulations (e.g. ISO 13485, 21 CFR Part 820, etc.)

Benefits

Comp & perks

Health benefits – Medical, Dental, Vision
Personal and Vacation Time
Retirement & Savings Plan (401K)
Employee Stock Purchase Plan
Training & Education Assistance
Bonus
Referral Program
Service Awards
Employee Recognition Program
Flexible Work Schedules

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

software developmentfirmware developmentrisk managementdesign controldesign verificationdesign validationcybersecurityIEC 62304ISO 1348521 CFR Part 820

Soft Skills

technical leadershipcommunicationrelationship buildingcollaborationproblem solvinginvestigationcoordinationsubject matter expertise