Senior Manager, Systems Engineering

LivaNova•Nashville, TN

1d•$155,000 - $175,000

About The Position

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 Senior Manager, Systems Engineering 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 systems engineering principles to bring multiple engineering disciplines together. The role consists of: 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. General Responsibilities 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. Specific Responsibilities 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.

Requirements

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

Nice To Haves

Preferred certification in Systems Engineering (e.g., from INCOSE) or equivalent.
Advanced degree preferred.
Preferred experience in active implantables for neuromodulation
Preferred experience in developing complex electro-mechanical-software systems.
Change Control, Non-Conformance, Corrective Action and Preventive Action

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.