Senior Manager, Systems Engineering

$155,000 - $175,000 + discretionary annual bonus. Pay ranges may vary by location and will be awarded based on experience.

401(k)

United States, Georgia, Atlanta

• 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 Liva Nova 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 Liva Nova 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 Liva Nova 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.

• 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 TIR
  45, 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
• 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

• 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.

Moderate travel may be required (up to 25%)

A reasonable estimate of the annual base salary for this position is $155,000 - $175,000 + discretionary annual bonus. Pay ranges may vary by location and will be awarded based on experience.

• Health benefits -…