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COCompany 359 LivaNova Deutschland GmbH

Senior Director Hardware Engineering(m/w/x)

München
Full-timeOn-siteSenior

Design and prototype electrical circuits, power management, and connectivity solutions for Class II/III medical devices at a global medtech firm. Proven background in medical device industry leadership and Class II/III regulatory submissions required. Lead multi-layered, cross-disciplinary teams, define hardware engineering roadmap.

Requirements

  • Solid experience leading multi-layered teams, vision definition, performance and behavior driving
  • Proven background in hardware engineering and medical device industry leadership
  • Solid electrical engineering experience and knowledge
  • Proven track record in Class II/III medical device development and regulatory submissions
  • Strong expertise in circuit design, PCB layout, power electronics, sensors, wired/wireless connectivity, mechanical CAD, materials selection, thermal/mechanical design
  • Experience with design controls, risk management, verification/validation in regulated environments
  • Prior involvement in FDA 510(k), PMA, or EU MDR submissions
  • Excellent leadership, communication, and stakeholder management skills
  • Experience working with external development partners, contract manufacturers, or design firms
  • Skill in managing joint development efforts, communication, milestone tracking, and compliance
  • Bachelor’s or Master’s degree in Electrical Engineering, Mechanical Engineering, or related field experience
  • Familiarity with low-power design, wireless protocols (BLE, Wi-Fi, NFC), and IoT-enabled devices
  • Experience with DFM, supplier qualification, and mechanical manufacturing processes (injection molding, machining)
  • Knowledge of reliability engineering, accelerated life testing, and mechanical durability testing

Tasks

  • Define and execute the hardware engineering roadmap
  • Lead and mentor multi-layered, cross-disciplinary teams
  • Foster innovation, technical rigor, and continuous improvement
  • Drive change and set behavioral standards
  • Oversee design and prototyping of electrical circuits, power management, and connectivity solutions
  • Oversee design and prototyping of mechanical components, enclosures, and thermal management
  • Ensure scalability, manufacturability, and reliability of subsystems
  • Drive component selection
  • Drive schematic capture and PCB layout
  • Drive mechanical CAD design
  • Drive design reviews
  • Lead verification and validation of electrical and mechanical subsystems
  • Lead integration, environmental, and reliability testing
  • Ensure compliance with ISO, IEC, FDA, and EMC/EMI medical device standards
  • Partner with Quality and Regulatory Affairs
  • Support audits, submissions, and technical documentation
  • Collaborate with Systems and Software Engineering teams for seamless integration
  • Partner with Operations and Manufacturing Engineering for design transfer and scalability
  • Represent Hardware Engineering in executive reviews
  • Represent Hardware Engineering in regulatory interactions
  • Represent Hardware Engineering in supplier engagements

Work Experience

  • approx. 4 - 6 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • PCB
  • CAD
  • BLE
  • Wi-Fi
  • NFC
  • IoT
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Company 359 LivaNova Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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