Jeremie Macchi

𝐑𝐨𝐥𝐞: Developed the next-generation of portable cardiac stimulator designed for diagnostic EP studies (Class B medical device). This innovative system is renowned for its configurable, computerized stimulation capabilities, enabling precise and adaptable cardiac diagnostics. I worked in a multidisciplinary Agile team, collaborating closely with the product’s cardiologist owner, development engineers, and testing teams. Focused on enhancing software functionalities, ensuring regulatory compliance, and bridging the gap between clinical needs and technical execution. Focused on embedded software, firmware, hardware development, and regulatory compliance (FDA 510(k), ISO 13485, IEC 62304), and clinical trial support. 𝐊𝐞𝐲 𝐂𝐨𝐧𝐭𝐫𝐢𝐛𝐮𝐭𝐢𝐨𝐧𝐬: - 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: Developed advanced software functionalities for the cardiac stimulator, ensuring alignment with the specific requirements of cardiologists and adherence to regulatory standards. - 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: Authored and executed firmware integration test protocols, achieving 94% coverage of FDA requirements for submission. Developed FDA 510(k) software documentation (SRS, verification protocols, ISO 14971 risk files) to ensure compliance with IEC 62304. - 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧: Designed customized software for 3 clinical trials, expanding the device’s capabilities for cutting-edge cardiology treatments. - 𝐇𝐚𝐫𝐝𝐰𝐚𝐫𝐞 𝐃𝐞𝐬𝐢𝐠𝐧: Led the design and review of 8-layer PCBs, optimizing for manufacturability, signal integrity, and regulatory compliance. 𝐈𝐦𝐩𝐚𝐜𝐭: Collaborated effectively with a multidisciplinary team to deliver high-quality medical devices, gaining extensive experience in software, firmware, and hardware development within the medical device industry. This role enhanced my technical expertise and project management skills, contributing to the successful development and regulatory approval of critical medical devices.

𝐑𝐨𝐥𝐞: R&D Sustaining Engineer for dental prophylaxis and urological surgery devices, specializing in product lifecycle management, component obsolescence resolution, and device recertification (IEC 60601-1, ISO 13485). Employed by a leading medical device company, I ensured uninterrupted production and regulatory compliance for critical devices. Worked in a cross-functional environment, collaborating with suppliers, manufacturers, and regulatory bodies to resolve technical issues and manage recertification. Focused on hardware redesign, miniaturization, and global certification, ensuring devices met stringent industry standards. 𝐊𝐞𝐲 𝐂𝐨𝐧𝐭𝐫𝐢𝐛𝐮𝐭𝐢𝐨𝐧𝐬: - 𝐂𝐨𝐦𝐩𝐨𝐧𝐞𝐧𝐭 𝐑𝐞𝐩𝐥𝐚𝐜𝐞𝐦𝐞𝐧𝐭: Led the motor replacement for a urological device, avoiding production disruption. Selected an alternative motor, conducted verification and EMC testing updated safety reports, and implemented changes in compliance with ISO 13485. - 𝐌𝐢𝐧𝐢𝐚𝐭𝐮𝐫𝐢𝐳𝐚𝐭𝐢𝐨𝐧: Designed a miniaturized daughter board with a 25-ball WLCSP MCU, optimizing PCB layout to reduce costs while ensuring manufacturability and performance. - 𝐆𝐥𝐨𝐛𝐚𝐥 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧: Managed worldwide recertification for a Bluetooth module change. Prepared device samples, developed test software, and coordinated with accredited labs to ensure seamless compliance. 𝐈𝐦𝐩𝐚𝐜𝐭: Effectively managed multiple projects in collaboration with various departments, ensuring uninterrupted production and regulatory compliance. Gained in-depth knowledge of medical device industry standards, strengthening cross-functional collaboration and project execution. This role enhanced my expertise in hardware design, miniaturization, and global certification, contributing to the continuous improvement of critical medical devices.

𝐑𝐨𝐥𝐞: Medtech R&D Engineer at a specialized outsourcing and consulting company in the Medtech industry, focusing on innovative technical solutions and project execution in regulated environments. Played a major role in developing custom medical device solutions, from concept to regulatory approval. Focused on end-to-end electronics design, embedded firmware development, feasibility studies, and quality management systems, ensuring high precision, miniaturization, and compliance with industry standards. 𝐊𝐞𝐲 𝐂𝐨𝐧𝐭𝐫𝐢𝐛𝐮𝐭𝐢𝐨𝐧𝐬: - 𝐂𝐨𝐦𝐩𝐚𝐜𝐭 𝐄𝐥𝐞𝐜𝐭𝐫𝐨𝐧𝐢𝐜𝐬 𝐃𝐞𝐬𝐢𝐠𝐧: Led the development of a compact, battery-powered electronic board (35 mm × 10 mm) to drive a piezoelectric transducer. Managed the full electronics design, including battery integration and a ±70 Vpp boost stage, achieving significant miniaturization without compromising performance. - 𝐅𝐢𝐫𝐦𝐰𝐚𝐫𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: Developed embedded firmware drivers in C/C++ for medical devices, incorporating advanced features such as bootloader and Modbus integration. - 𝐅𝐞𝐚𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐲 𝐒𝐭𝐮𝐝𝐢𝐞𝐬: Conducted a proof-of-concept study for a surgical device with wireless communication and length-measurement capabilities, guiding technology selection and design decisions. - 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐒𝐲𝐬𝐭𝐞𝐦𝐬: Contributed to establishing a quality management system for an industrial client, enabling successful CE certification. 𝐈𝐦𝐩𝐚𝐜𝐭: Delivered high-precision, miniaturized medical electronics and supported clients in achieving regulatory approvals and technical innovation. Acquired technical expertise, problem-solving skills, and attention to detail, ensuring high-quality results through effective collaboration with cross-functional teams and customers. This role strengthened my ability to execute complex projects and drive innovation in the Medtech industry.

Master’s final internship as an Electronics Engineer in a neuroscience research laboratory, focusing on the development of an in vitro brain tissue study platform.

Bachelor’s final project - Development of a proof of concept to measure glucose levels in sweat.

Participation in the SwissSkills competition. A contest between Switzerland’s best young electronics technicians (9e place).

Working in the Electronic Broadcast department.

Student exchange for a semester in Canada at Laval University