LivaNova · 15 hours ago
Senior Manager, Systems Engineering
Nashville, TN
Full-time
Hybrid
Senior Level
$155K/yr - $175K/yrLivaNova is a global medtech company dedicated to changing the trajectory of lives through innovative solutions. The Senior Manager, Systems Engineering will lead the development and commercialization of medical device products by applying systems engineering principles and collaborating with cross-functional teams to ensure quality and performance standards are met.
Health CareMedical DeviceNeuroscience
Responsibilities
Leading organization within systems engineering, risk management and design control including process improvement, best practices and tools for operational excellence
Managing, mentoring, coaching and developing Systems Engineering team for individual career development consistently with organization strategy
Collaborating with cross-functional teams, internal and external stakeholders to meet project objectives
Defining and decomposing design inputs into systems, subsystems and interfaces to enable each applicable function to design, verify and validate the product
Analyzing and comparing technological tradeoffs to enable cross-functional decisions including, for example, power budget, tolerance analysis, reliability analysis, error budget, design and supplier/component evaluations
Analyzing system risks and identifying appropriate risk control measures
Developing design verification and validation strategy in collaboration with functional owners to demonstrate that design outputs meet design inputs
Completing Traceability Matrices demonstrating that Design Outputs meet Design Inputs with objective evidence, e.g., design verification or validation reports
Identifying, investigating, planning, implementing and/or leading the disposition of defects, non-conformance investigation, Corrective Actions and Preventive Actions and/or Change Control
Contribute to and execute LivaNova Innovation milestones including project schedule and budget, provide periodic progress reports and own issue resolution in collaboration with internal and external stakeholders
Contribute and comply with LivaNova Quality Management System procedures, applicable regulations and standards resulting in quality records
Contribute to the intellectual property position of the company by recording and submitting invention proposals
Maintain current knowledge of competitive and state of the art technologies
Recognize and analyze technical problems and provide possible solutions, such as product redesign, substitution of material or parts, or rearrangement of parts or subassemblies
Contribute to preparation of registration dossiers for timely approval; defend deliverables to internal or external auditors
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
Subject matter owner of systems engineering, risk management and design control in collaboration with other appropriate stakeholders
Business owner of appropriate IT applications, e.g., requirement management and risk management
Develop and document system architecture(s) including, for example, hardware, software, interfaces and operational conditions
Define and maintain user needs, system requirements, standards, subsystem requirements and risk control measures/safety requirements and appropriate traceability matrices in an applicable requirement management system
Contribute to risk management including assessing systems risks and identifying appropriate risk control measures
Lead design verification strategy, plan, protocols, execution and reports to demonstrate that design outputs meet design inputs
Set up test equipment and conduct testing to evaluate design concepts or execute design verification protocols
Qualification
Required
Systems Engineering (e.g., INCOSE certification or MBSE) – expert
Design Control Engineering and medical device product development process (e.g., ISO 13485 & 21 CFR 820.30) - good
Software development including agile methodologies and design for cybersecurity, e.g., IEC 62304, AAMI TIR45, agile software development, e.g., Scrum - some
Risk management (e.g., ISO 14971) including Usability risk (e.g., IEC 62366-1) - expert
Engineering/scientific analysis and appropriate tools
Requirement management and risk management tools
Bachelor of Science (BS) or higher degree in an engineering discipline or equivalent
Moderate travel may be required (up to 25%)
Preferred
Preferred experience in active implantables for neuromodulation
Preferred experience in developing complex electro-mechanical-software systems
Preferred degree in Systems Engineering, Biomedical Engineering, Clinical Engineering, Electrical Engineering, Software Engineering or equivalent
Preferred certification in Systems Engineering (e.g., from INCOSE) or equivalent
Advanced degree preferred
Benefits
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
Company
LivaNova
LivaNova is a medical technology company that specializes in advanced cardiac surgery, neuromodulation, and circulatory support solutions.
Founded in 1987
1001-5000 employees
H1B Sponsorship
LivaNova has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (7)
2023 (6)
2022 (7)
2021 (9)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$300M2024-03-05Post Ipo Debt· $300M
2015-10-19IPO
Leadership Team
Vladimir Makatsaria
Chief Executive Officer
Alex Shvartsburg
Chief Financial Officer
Recent News
2025-12-24
MarketScreener
2025-12-02
Company data provided by crunchbase