Senior Manager, Systems Engineering

K-Recruiting Life Sciences; Houston (TX); Híbrido; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

LivaNova seeks a Senior Systems Engineer to lead systems engineering, risk management and design control across medical device programs. You will guide cross-functional teams to decompose design inputs, develop verification/validation strategies and ensure regulatory compliance.

The role emphasizes mentoring, collaboration with stakeholders, and maintaining rigorous traceability and documentation in a regulated environment.

Formación

• Experience with design controls for medical devices per ISO 13485 and 21 CFR 820.30.
• Expert in systems engineering (INCOSE/MBSE).
• Strong risk management and traceability practices.

Responsabilidades

• Lead systems engineering, risk management and design control in collaboration with stakeholders.
• Mentor and develop Systems Engineering team for career growth.
• Collaborate with cross-functional teams to meet project objectives.
• Define and decompose design inputs into systems and interfaces for design, verification and validation.
• Develop risk assessments and risk control measures; manage traceability matrices.

Conocimientos

Systems Engineering

Leadership

Technical writing

Communication

English

Regulatory knowledge

Project management

Educación

BS in Engineering

INCOSE certification

MS preferred

Herramientas

MBSE tools

Regulatory documentation tools

Descripción del empleo

Note: Preference is Houston-based, with Hybrid in-office (3 days/week), but Remote is acceptable. In the case of remote, willingness to travel is important (quarterly).

Position Summary:

This position contributes to the development and commercialization of medical device products in support 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.

Skills and Experience:

• General:
• English – excellent spoken and written
• Technical writing (in a regulatory environment) – good
• Communication – good
• Leadership – good
• Specialized:
• 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
• Engineering/scientific analysis and appropriate tools
• Requirement management and risk management tools
• 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
• The minimum requirements, skills and qualifications contained in this job description outline the core functions and requirements of the position and do not constitute an exhaustive listing of activities, duties, or responsibilities that may be required of or assigned to an employee in this position at the Company’s discretion. Further, the ability to meet the minimum requirements and/or possession of the stated skills and qualifications do not imply or establish that an individual will be employed in this position.

Education:

• 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.
• Preferred certification in Systems Engineering (e.g., from INCOSE) or equivalent.
• Advanced degree preferred.

Travel Requirements:

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