About the roleThe R&D Tech Lead / Staff Engineer plays a critical role in driving innovation and excellence in the development of cutting-edge medical products and technologies. This position blends deep technical expertise with leadership and systems engineering, guiding cross-functional teams through every stage of the product lifecycle—from initial concept and design to commercialization and post-market support. The role demands a strong understanding of regulatory compliance, ensuring that all documentation and traceability requirements are met for successful submissions. With a focus on shaping product architecture and defining system and sub-system requirements, the Tech Lead is instrumental in delivering safe, effective, and transformative healthcare solutions. In this dynamic and regulated environment, the Tech Lead also serves as a mentor and technical authority, fostering growth and collaboration across engineering teams. Their influence extends beyond technical execution, helping to cultivate a culture of innovation and continuous improvement. By aligning engineering efforts with strategic goals, they ensure that the organization remains at the forefront of medical technology development. This is a unique opportunity for a highly motivated individual to make a meaningful impact on patient lives while advancing their career in a fast-paced and purpose-driven setting.Main responsibilitiesSystem Design & Development: Lead system-level design and development for new and existing medical products, ensuring alignment with stakeholder needs.Requirements & Architecture: Define product architectures and translate stakeholder inputs into clear, traceable system requirements.Integration & Testing: Oversee system integration and testing activities, supporting verification and validation across hardware, software, UX, and systems.Technical Leadership: Provide mentorship and technical guidance to cross-functional teams, promoting engineering excellence.Documentation & Tools: Own and maintain design control documentation, SOPs, and requirements using tools like DOORS and Modern Requirements.Lead configuration/change control processes (e.g., CCB, CIT) and find opportunities for development optimisation.Regulatory Compliance: Ensure compliance with ISO 13485, ISO 14971, FDA QSR, and support FDA submissions through collaboration with quality and regulatory teams.Risk Management: Conduct risk assessments and implement mitigation strategies, contributing to activities like dFMEA and hazard analysis.Multi-functional Collaboration: Work closely with Engineering, Quality, Regulatory, Manufacturing, and Marketing to ensure smooth project execution and post-market support.Project Execution & Tools Development: Develop project plans, technical documents, and Excel- based toolsets to streamline workflows and support design control processes.About youProven experience in leading technical project teams (HW, SW, UX, Systems) through the product lifecycle and phase-gate approach.Strong ability to lead large teams and communicate technical deliverables effectively.Experience in writing SOPs, guidance, and technical documentation.Proficiency in Microsoft Project, Excel, especially in writing macros.Experience in cross-functional product development.Preferred QualificationsBachelor’s or Master’s degree in Engineering, Systems Engineering, Biomedical Engineering, or related field.5+ years of progressive experience as a senior/lead engineer in product development.Creative problem solver with the ability to resolve conflicting requirements and technical risks.Practical experience in configuration management and change control processes.Familiarity with tools like DOORS, Modern Requirements, SolidWorks, MATLAB, LabVIEW, Minitab.
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