Tech Lead

3 days ago

Limerick, Ireland Morgan McKinley Full time

R&D Tech Lead / Staff Systems Engineer Company Overview Our client is a global leader in medical technology, dedicated to developing innovative solutions that improve patient outcomes and advance healthcare worldwide. Their multidisciplinary R&D teams work on cutting-edge devices that combine electronics, mechanics, and software, with a strong focus on safety, reliability, and regulatory compliance. By fostering collaboration and technical excellence, they deliver technologies that make a lasting difference in people's lives. Role Overview We are seeking a highly experienced R&D Tech Lead / Staff Systems Engineer to play a pivotal role in guiding the development of advanced medical products. This is a senior-level systems engineering position, where you'll lead a small cross-functional R&D team through the full product lifecycle - from concept and requirements management to commercialization and post-market support. The role is not hands-on coding but requires strong technical and systems engineering expertise, regulatory alignment, and proven leadership in delivering complex projects. Acting as a central point of contact, you'll ensure timely delivery, robust documentation, and compliance with international standards while mentoring team members and driving innovation. Key Responsibilities Lead systems engineering activities for new and existing R&D projects. Oversee the full product lifecycle, including requirements management, risk analysis, and regulatory alignment. Manage configuration and change control processes to maintain product integrity. Ensure system and sub-system requirements are clear, traceable, and aligned with stakeholder needs. Support material testing, product specifications, and system integration activities. Collaborate with Quality, Regulatory, Manufacturing, and Marketing to ensure successful delivery and post-market support. Conduct risk management activities such as hazard analysis and dFMEA. Provide technical leadership, mentoring, and direction to cross-functional teams. Drive delivery against project timelines while ensuring compliance with standards such as ISO 13485, ISO 14971, and FDA QSR. Requirements Bachelor's or Master's degree in Engineering, Systems Engineering, Electronics, or related field. 5+ years of experience in product development, preferably within regulated industries. Strong background in systems engineering, requirements management, and regulatory compliance. Proven track record in leading R&D or systems engineering projects through the full lifecycle. Knowledge of configuration management and change control processes. Excellent communication and leadership skills, with the ability to collaborate across multidisciplinary teams. This is an exciting opportunity to take on a senior technical leadership role where you'll shape the development of life-changing healthcare technologies. If you're looking to apply your systems engineering expertise in a role with significant impact, we'd love to hear from you. Skills: tech lead System engineering comploiance system design regulated environment

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