Sinclais is seeking a Hardware Technical Lead at their R&D department located in Esplugues del Llobregat.
The Hardware Technical Lead mission will be to provide electronics and system designs that fulfill product requirements and regulatory standards following the quality standards set by the company.
About Sinclair
* Bachelor's degree in electronic, telecommunications or a related field;
* 10 years of experience in electronic development;
* Proven track record of successful electronic development projects in the medical device industry, from concept to commercialization;
* Advanced degree in electronic, telecommunications or a related field;
* 2 years of experience in an electronic development leadership role;
* In-depth knowledge of hardware design principles, including analog and digital circuit design, PCB layout, and signal integrity;
* Experience with medical device regulations and standards, such as FDA QSR, ISO 13485, IEC 60601, and IEC 62304;
* Strong leadership, communication, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams;
* Excellent problem-solving skills and attention to detail, with a commitment to quality and compliance;
* Experience with design control processes, risk management, and design for manufacturability and reliability;
* Proficiency in CAD tools (e.g., Altium Designer, OrCAD) and simulation tools (e.g., SPICE, MATLAB);
* Achievement orientation;
* Adaptability and openness to change;
* Learning capacity;
* Integrity and professional ethics;
* Cross-cutting cooperation;
* Creativity, originality, and innovation;
* Time management, organization, and planning;
* Capacity for analysis and critical thinking;
* Team development and management.
Key Responsibilities
* Lead a team of hardware engineers in the design, development, and testing of medical devices, including electromechanical systems, sensors, and embedded systems;
* Define hardware requirements and specifications based on product requirements and regulatory standards;
* Develop hardware architecture and design solutions that meet performance, reliability, and regulatory requirements;
* Lead the electrical safety compliance testing in accordance with IEC 60601-1 and its collateral and particular standards;
* Lead the delivery of prototype devices for V&V activities;
* Plan and execute hardware development projects, including resource allocation, scheduling, and risk management;
* Collaborate with cross-functional teams to integrate hardware with software, firmware, and mechanical components;
* Lead design reviews, risk assessments, and verification and validation activities to ensure product quality and compliance with regulatory standards;
* Follow the existing project management procedure within the company in accordance with ISO 13485 standard and the department's working methodology, and ensure that quality processes are followed and implemented on time;
* Drive continuous improvement in hardware design processes, tools, and methodologies;
* Provide technical guidance and mentorship to hardware engineers, fostering a culture of innovation, collaboration, and excellence;
* Lead the collaboration with new product introduction, manufacturing, and quality departments for the industrialization of new designs providing support on the assembly and verification instructions, design of verification tools, training, and parts homologations;
* Support sustain activities for finding alternative components;
* Lead the collaboration with other departments such as Regulatory, Clinical, Quality, Service, Sustain Group, Operations, Sales, Manufacturing, NPI, and MKT;
* Collaboration in the creation of "R&D&I" reports;
* Design of architectures, electronic parts, analog and digital circuits;
* Search, homologation, and management of suppliers of electronic components;
* Electronic assembly, integration, and verification testing.
Benefits We offer :
* Competitive fixed salary aligned with the market + variable;
* Medical + Dental Insurance;
* Fruit at the office;
* Enjoyable, dynamic, and international environment.
We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability, and autonomy. The company is full of opportunity for those who wish to grasp it.
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