Senior Electronic Design Engineer with experience in the design of Medical Devices required by high-growth medical devices company in Galway.

From it’s headquarters in Galway, my client designs highly sophisticated life-saving medical devices. Due to expansion in global markets, they are growing their design team yet again.

Collaborating with a cross-functional team, you will conduct product design and development in accordance with CE & FDA regulations for medical device design and manufacture for global markets.

Requirements:

• Degree in Electronic Engineering / similar
• 8+ years experience in an Electronic design role
• Design experience in the medical devices sector
• Proficient in electronic circuit design – analog and digital
• Working knowledge of IEC/EN 60601 Series for Medical Electrical Equipment
• Experience in creating the hardware deliverables required for medical electrical device development
• Experience of hardware validation for medical electrical equipment
• Experience using development tools such as OrCAD Capture and PCB Designer
• Knowledge of Microcontroller interfacing such as SPI, I2C, UART, ADCs etc.
• Strong interpersonal skills with the ability to collaborate in a multi-disciplinary team
• Self-directed with effective time-management skills
• Flair for innovation
• Ability to document engineering evolution, development, testing, and reporting using MS Office applications such as Word, Excel, PowerPoint etc.

Responsibilities:

• Conduct product design and development in accordance with CE & FDA regulations relating to medical device design and manufacture
• Collaborate as a member of cross-functional project teams in developing products from concept through to commercialization
• Conduct product design and development in accordance with CE & FDA regulations relating to medical device design and manufacture
• Conduct product design in accordance with the project objectives with due consideration of project schedule, budget, risks, regulatory submission, standard compliance
• Conduct use and design risk assessment, implementing controls or mitigations to reduce risk levels
• Conduct and record proof of principle testing of prototypes to confirm feasibility of ideas and concepts
• Engage with clinicians and product users in their clinical setting to elicit user need/functional requirements
• Prepare technical documentation in clear and concise terms in accordance with good engineering practice
• Participate in technical design reviews to ensure electrical design integrity and safety are achieved
• Apply failure analysis skills to determine and document root cause of product system or component failure
• Conduct assessment of the competitive IP landscape, including freedom to operate and literature review
• Prepare invention disclosures and patent applications to ensure protection of intellectual property
• Maintain current and accurate records of the iterative design process, trial and error and experimental steps to support the design history file and for R&D grant and tax credit submissions
• Liaise closely within R&D, Science, Manufacturing, Operations, Quality, Sales and Marketing functions through the product development lifecycle
• Maintain current working knowledge of the key international standards, regulations and regulatory guidance direction that govern the medical devices industry including medical electrical equipment
• Communicate regular and accurate updates on project deliverables including any risk of divergence from the plan to the project leader and/or management
• Maintain and enhance engagement and positive culture within the team and organization
• Demonstrates and models through leadership style and behavior, respect for company core values and a commitment to teamwork
• Technical input and review of related project documentation
• Prepare invention disclosures and patent fillings as appropriate
• Support of medical electrical equipment manufacturing from prototype to production and sustaining of same