Principal Design Verification Engineer

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow-because at LivaNova, we don't just treat conditions - we aspire to alter the course of lives.

The Principal Design Verification Engineer contributes to the development and commercialization of medical device products in support of LivaNova Innovation objectives. The purpose of this position is to develop and launch commercially successful products that meet customers' needs and expectations of performance, safety and quality by applying the latest verification and quality engineering principles.

The role consists of:

• Collaborating with cross-functional teams, internal and external stakeholders to meet project objectives.

• Leading, developing and executing design verification strategy for hardware and software across multiple functions and third-parties to demonstrate that product design outputs meet design inputs.

• Developing and executing test protocols and reports with primary focus on system integration.

• Identifying, procuring, setting up and validating test equipment and test fixtures to support design verification strategy.

• Identifying and implementing test automation opportunities based on cost-benefit considerations.

• Assessing impact of design changes and identifying, executing and documenting regression test strategy to demonstrate product safety and performance.

• Identifying, investigating, planning, implementing and leading the disposition of defects, non-conformance investigation, Corrective Actions and Preventive Actions and/or Change Control.

General Responsibilities

• Meet LivaNova Innovation milestones including project schedule and budget, provide periodic progress reports and own issue resolution in collaboration with internal and external stakeholders.

• Comply with LivaNova Quality Management System procedures and applicable regulations and standards resulting in quality records.

• Contribute to preparation of registration dossiers for timely approval; defend deliverables to internal or external auditors.

• Contribute to the intellectual property position of the company by recording and submitting invention proposals.

• Perform other duties as may be requested by management.

• Work daily with a high level of integrity and promote a diverse and inclusive workplace culture in both people and thought consistent with LivaNova values.

Specific Responsibilities

• Ensure that requirements are verifiable in collaboration with systems engineering and other stakeholders.

• Analyze system architecture and operational conditions to develop a comprehensive design verification strategy best suited to each project.

• Define, lead and execute design verification strategy including protocols, test prototypes, software builds, test conditions and reports.

• Define, execute and document test cases/protocols to verify system-level and technical requirements including defining sample size, prototype configurations, test conditions and acceptance criteria.

• Confirm and document in a design verification summary report that the design verification strategy has been executed and that design outputs meet all design inputs.

• Analyze requirements and test results as appropriate.

• Define, procure, set up and validate new test methods and equipment.

• Analyze impact of proposed design changes to identify and execute most effective regression testing strategy.

Skills and Experience

• Verification Engineer, Design Verification Engineer, Systems Verification Engineer, Test Engineer, Systems Test Engineer,

• Medical device product development (e.g., 21 CFR 820.30 & ISO 13485), risk management (e.g., ISO 14971) and associated processes (e.g., IEC 60601-1, IEC 62304) - see Appendix Table 1

• Test method/equipment development and validation

• Test automation or requirement management applications

• Software testing including mobile, cloud and web browser applications

• Working knowledge of Git and Object Oriented Programming (OOP), e.g., C/C++/C#, Java, Python.

• Preferred experience in active implantables for neuromodulation

• Preferred experience in verifying complex electro-mechanical-software systems.

• Change Control, Non-Conformance, Corrective Action and Preventive Action

Education

• Bachelor of Science (BS) or higher degree in an engineering discipline or equivalent.

• Preferred degree in Systems Engineering, Electrical Engineering, Software Engineering, Biomedical Engineering, Mechanical Engineering or equivalent.

Pay Transparency

• A reasonable estimate of the annual base salary for this position is $150,000 - $175,000 plus discretionary annual bonus. Pay ranges may vary by location and will be awarded based on experience.

Location & Travel Requirements

• Location: Clear Lake (Southeast Houston, TX area)

• Hybrid Schedule: 3 days onsite, 2 days working from home; Normal business hours are Monday- Friday, from 8:00a- 5:00p.

• Moderate travel may be required (up to 25%)

Employee benefits include:

• 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

Welcome to impact. Welcome to innovation. Welcome to your new life.