Senior Electronic Engineer (with Medical Devices experience) Permanent employee, Full-time · Barcelona Your mission As a Senior Electronics Engineer, you will play a crucial role in developing cutting-edge medical devices, with a strong emphasis on advanced medical electronic systems that form part of a complex CNS neurostimulation implant and its peripherals.
This active implantable medical device will be launched in both the EU, requiring CE mark certification under MDR, and in the USA, necessitating FDA approval.
In this dynamic position, you will: Research, architect, and design innovative electronic subsystems.
Develop and test these systems to ensure top-level performance and compliance with regulatory standards.
Your expertise will directly contribute to life-changing healthcare solutions that push the boundaries of medical technology.
Main responsibilities: Lead the development of electronic circuits for medical devices, specifically for an implantable neurostimulation system, working closely with mechanical and software engineering teams as well as quality and regulatory teams.
Develop medical devices in compliance with relevant standards (e.g., IEC-60601, ISO-14708).
Manage external partners for outsourced design, assembly, and testing of electronic systems that are part of the neurostimulation system.
Guide the development team in translating system requirements into hardware and embedded software requirements, including defining interfaces.
Contribute to technical concepts and assess their technical feasibility.
Perform functional analysis and create system designs that meet specified requirements.
Apply risk management principles, including conducting Design Failure Mode and Effect Analysis (DFMEA).
Define test strategies to verify that electronic systems meet product and manufacturing requirements.
Lead and participate in system integration, verification, and validation activities.
Ensure traceability between system requirements and test records/reports.
Initiate and lead design reviews, technical reviews, and milestone reviews.
Generate intellectual property through innovative design and development.
Apply DFR/DFM/DFT principles (Design for Reliability, Manufacturing, and Test), including concept engineering, modeling, analysis, sensitivity, and statistical analysis.
Collaborate intensively with Quality, Regulatory, Clinical, and Project Management teams to ensure compliance with formal product development processes, including conducting design and phase reviews.
Follow change request processes to implement necessary design changes.
Your profile Bachelor's or Master's degree in Electronics Engineering, with a minimum of 8 years of experience in medical device development, including full development cycle execution.
Proven expertise in analog and PCB design for implants, adhering to IPC standards.
Preferably experienced in analog IC design.
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