LivaNova
Improving Quality of Life Through Innovation. Every Patient, Every Day
Senior Manager, Systems Engineering
Location
Illinois + 2 moreAll locations: Illinois, Tennessee, Texas
Posted
54 days ago
Salary
$155K - $175K / year
Bachelor DegreeEnglishCyber Security
Job Description
• 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.
Job 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
- 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
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