LivaNova

Improving Quality of Life Through Innovation. Every Patient, Every Day

Senior Manager, Systems Engineering

Full TimeRemoteTeam 1,001-5,000H1B SponsorCompany SiteLinkedIn

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

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