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
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.
- 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.
- Strong system-thinking skills, with the ability to identify areas for improvement and develop actionable plans. A team player and effective collaborator with colleagues across disciplines.
- Proficiency in electronic simulation and design tools, such as Spice, Altium, and VHDL.
- Experienced in verification test design and execution, with preferred experience in developing verification tools.
- Solid understanding of medical risk analysis techniques, including FMEA (Failure Mode and Effects Analysis).
- In-depth knowledge of medical device development standards and experience applying standards such as IEC-60601 and ISO-14708 in implantable electronics and electrical safety design.
- Familiarity with implantable device design, including mechanical and software aspects.
- Preferred experience in digital communication protocols, such as I2C, SPI, and UART, as well as FPGA and embedded design.
- Preferred experience in designing and testing for MRI compatibility.
- Preferred strong background in neuroscience, with an interest in further developing expertise in this area.
- Preferred experience in designing charging solutions for active implantable medical devices.
- Proven ability to manage outsourced projects and collaborate effectively with external subcontractors.
- Fast learner, self-motivated and pro-active individual able to work in the fast-moving environment of a dynamic start-up company
- Fluency in English required (English is company language). Fluency in Spanish is a plus.
At INBRAIN we believe in shared success and diverse ways of thinking, here you'll learn, grow, and advance in an innovative culture
WHAT CAN WE OFFER TO YOU?
- A collaborative environment where innovative ideas flourish and teamwork drives us forward. At INBRAIN, we believe the power of collective intelligence is unique. You will be part of a team that thrives on open communication, knowledge sharing and mutual respect.
- Meaningful Work Impact: Our projects are not only exciting and challenging but also have a positive impact on the industry and society as a whole. You'll be part of a team that strives to create meaningful change.
- Cutting-Edge Technology Exposure: Joining us means immersing yourself in the latest technologies and innovative solutions. You'll have access to state-of-the-art tools and resources, fostering continuous learning and keeping your skills relevant in a rapidly evolving industry.
- Competitive salary (according to your experience/skills)
- Payflow & Flexflow
- Private Health Insurance (optional)
- Training bonus for professional development.
- 23 vacation days per year + 24th and 31st of December.
- Hybrid working modality
At INBRAIN, we're not just offering a job – we're inviting you to be part of a transformative journey, Are you ready to transform lives? Join us!
#diverseandinclusive
We believe that a diverse and well-balanced workforce drives innovation. At INBRAIN, we foster the inclusion of all people regardless of culture, age, gender, sexual orientation identity or any other status
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