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Senior Director Hardware Engineering(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- PCB
- CAD
- BLE
- Wi-Fi
- NFC
- IoT
Noch nicht perfekt?
- MobileyeVollzeitnur vor OrtSeniorMünchen
- LivaNova Deutschland GmbH
Senior Director of Software Systems & Digital Platforms(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - LivaNova Deutschland GmbH
Senior Firmware Engineer(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - LivaNova
Project Head – R&D(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - Filics
Electrical Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMünchen
Senior Director Hardware Engineering(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- PCB
- CAD
- BLE
- Wi-Fi
- NFC
- IoT
Über das Unternehmen
Company 359 LivaNova Deutschland GmbH
Branche
Healthcare
Beschreibung
LivaNova is a global medtech company creating ingenious solutions to ignite patient turnarounds and change the trajectory of lives.
Noch nicht perfekt?
- Mobileye
Senior HW Design Engineer(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - LivaNova Deutschland GmbH
Senior Director of Software Systems & Digital Platforms(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - LivaNova Deutschland GmbH
Senior Firmware Engineer(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - LivaNova
Project Head – R&D(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - Filics
Electrical Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMünchen