Visionary Technical Leader Wanted

About this role:

This is a highly sought-after opportunity for a talented and experienced Technical Lead to join our team. The ideal candidate will have a strong background in engineering, excellent leadership skills, and the ability to drive innovation and excellence in the development of cutting-edge medical products and technologies.

The Technical Lead will play a critical role in guiding cross-functional teams through every stage of the product lifecycle, from initial concept and design to commercialization and post-market support. This position demands a strong understanding of regulatory compliance, ensuring that all documentation and traceability requirements are met for successful submissions.

The Tech Lead will be responsible for leading system-level design and development for new and existing medical products, defining product architectures, translating stakeholder inputs into clear, traceable system requirements, and overseeing system integration and testing activities.

The ideal candidate will have a proven track record of leading technical project teams through the product lifecycle and phase-gate approach, with experience in writing SOPs, guidance, and technical documentation. They will also have proficiency in Microsoft Project, Excel, especially in writing macros, and experience in cross-functional product development.

We are looking for a creative problem solver with the ability to resolve conflicting requirements and technical risks, who is familiar with tools like DOORS, Modern Requirements, SolidWorks, MATLAB, LabVIEW, Minitab, and has a Bachelor's or Master's degree in Engineering, Systems Engineering, Biomedical Engineering, or related field.

Main responsibilities:

• System 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 you:

• Proven 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 QUALIFICATIONS:

• Bachelor'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.