We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
• The technical role in electrical design, test, and documentation to meet compliance and performance requirements and satisfy customer needs of medical electro-mechanical systems.
• Responsible for the architecture, analysis, and development of hardware systems and components including circuit boards, power systems, processors, etc. for use in medical devices.
• Deliver high quality design, in a timely fashion and in accordance to medical device regulations (IEC 60601-1, ISO 13485, FDA US21CFR820, and CE MDR 2017/745)
• Collaborate with a multi-disciplinary cross of Software, Mechanical and biomedical engineers to progress a project from concept phase into commercialization phase
• Collaborate with operations engineers and vendors for production standards, test strategies and implementation.
• Hardware testing and troubleshooting, including board bring-up, design of test tooling and adaptation of existing platforms to new specifications.
• Plan through all project phases, strategy and execution of measurement system development/qualification, design verification and validation
• Identify and mitigate technological risks throughout the design process
• Evaluate and implements designs to ensure that all agency requirements (UL, IEC, FDA) are being met throughout the design process
• Interface effectively and build relationships with team members, other staff and key technology and component suppliers, both locally and globally
• Coach, mentor and delegate work to less experienced engineers
Education & Experience
• We are looking for a qualified person with a minimum of Degree level 8 in Electrical Engineering or Equivalent with a minimum 8 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience – additional relevant qualifications may be advantageous.
• Experience of EMC testing including Conducted and Radiated Immunity, Conducted and Radiated Emissions, Current Leakage, and ESD Testing.
• Knowledge and experience in design of embedded microcontroller-based electronics devices, including FPGA-based, digital and analog design.
• Knowledge and experience using CAD systems for printed circuit board design (e.g. Altium, Cadence, OrCAD, Allegro PCB) and data acquisition software (LabVIEW))
• We are looking for a dynamic team player and leader that can work effectively and proactively on cross-functional teams.
• Ideally have experience in developing hardware solutions for medical devices or related industries
• Experience testing electronic devices to meet immunity and emissions requirements
• Experience in developing verification and validation protocols
• You are a seasoned professional in Hardware Engineering development with extensive engineering knowledge and skills in some or all of the following: component and system design, electrical/electronic system design in compliance with IEC 60601-1, miniaturized low-power electronic system design, schematic capture and PCB layout tools.
• We are looking for strong communication and presentation skills and fluency in English, both in writing and speaking.