Senior Director Hardware Engineering

Senior Director Hardware Engineering

LivaNova

Munich, Germany

We are seeking an accomplished Senior Director of Hardware Engineering to lead the design, prototyping, and verification of both electrical and mechanical components and subsystems for our medical device portfolio. This leader will oversee the full lifecycle of hardware engineering activities - from concept through commercialization - ensuring compliance with global regulatory standards, robust design controls, and seamless integration with software and systems teams.

If you are looking for opportunities to apply your technical and leadership skills to drive performance and innovation whilst fostering a culture of excellence within the organization, this might be the role for you!

Leadership & Strategy

• Define and execute the hardware engineering roadmap in alignment with product and business strategy, covering both electrical and mechanical domains.
• Lead and mentor multi-layered (incl. people managers) and cross-disciplinary teams of electrical engineers, mechanical engineers, and verification specialists.
• Foster a culture of innovation, technical rigor, and continuous improvement across hardware engineering, driving change and setting behavioural standards.

Design & Development

• Oversee design and prototyping of analog, digital, and mixed-signal circuits, power management, connectivity solutions, as well as mechanical components including enclosures, mechanisms, thermal and fluid management.
• Ensure scalability, manufacturability, and reliability of both electrical and mechanical subsystems.
• Drive component selection, schematic capture, PCB layout, mechanical CAD design, and design reviews.

Verification & Compliance

• Lead verification and validation of electrical and mechanical subsystems, including integration, environmental, and reliability testing.
• Ensure compliance with applicable standards and regulations, including:
  • ISO 13485 (Quality Management Systems for Medical Devices)
  • IEC 60601 (Medical Electrical Equipment Safety)
  • IEC 61010 (Electrical Safety for Laboratory Equipment, if applicable)
  • IEC 62304 (Software Lifecycle, for embedded systems)
  • ISO 14971 (Risk Management)
  • FDA 21 CFR Part 11/820 (Design Controls, QSR)
  • EMC/EMI standards (IEC 60601-1-2, FCC, CE)
• Mechanical standards and guidelines relevant to medical devices (e.g., ISO 10993 biocompatibility, mechanical durability testing)
• Partner with Quality and Regulatory Affairs to support audits, submissions, and technical documentation.

Cross-Functional Collaboration

• Collaborate with Systems and Software Engineering teams to ensure seamless integration of subsystems.
• Partner with Operations and Manufacturing Engineering to ensure design transfer, manufacturability, and scalability.
• Represent Hardware Engineering in executive reviews, regulatory interactions, and supplier engagements.

ABOUT YOU

Essential

• Solid experience leading multi-layered teams (incl. people managers), defining vision and driving performance and behaviours
• Proven background in hardware engineering, with solid track record in leadership roles within the medical device industry.
• Solid experience and knowledge of electrical engineering is essential
• Proven track record in Class II/III medical device development and regulatory submissions.
• Strong expertise in circuit design, PCB layout, power electronics, sensors, connectivity (wired/wireless), mechanical CAD, materials selection, and thermal/mechanical design.
• Experience with design controls, risk management, and verification/validation in regulated environments.
• Prior involvement in FDA 510(k), PMA, or EU MDR submissions.
• Excellent leadership, communication, and stakeholder management skills.
• Demonstrated experience working with external development partners, contract manufacturers, or design firms.
• Skilled in managing joint development efforts, ensuring clear communication, milestone tracking, and compliance across organizations.
• Bachelor’s or Master’s degree in Electrical Engineering, Mechanical Engineering, or related field experience

Beneficial

• Familiarity with low-power design, wireless protocols (BLE, Wi-Fi, NFC), and IoT-enabled devices
• Experience with design for manufacturability (DFM), supplier qualification, and mechanical manufacturing processes (e.g., injection molding, machining)
• Knowledge of reliability engineering, accelerated life testing, and mechanical durability testing