Senior Manager, Systems Engineering

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

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. Liva Nova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow – at Liva Nova,
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 Liva Nova 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.

• 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 – 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