Neromodulation
In this role, I led the charge on four pivotal New Product Development (NPD) projects. These projects spanned from the initial planning stages through to successful execution, where I managed to navigate and overcome significant challenges in resource allocation and equipment scheduling. This strategic management helped avoid downtime and maintained continuous testing cycles, ensuring that project timelines and quality standards were met.One of my key achievements was revolutionizing our testing processes. I implemented a new assessment strategy that dramatically reduced the feasibility testing time from six months to just four weeks. Additionally, I enhanced our testing effectiveness and risk management by conducting a sensitivity analysis that reduced test parameters from 70,000 to just 700, streamlining operations and improving precision.I spearheaded a critical MRI labeling project for spinal cord devices, ensuring full compliance with European safety standards. This project involved documentation and safety assessments, and I prepared and oversaw the safety assessment documentation for FDA and BSI submissions. This not only ensured device safety for clinical trials but also met the rigorous standards of ISO 10974.My leadership extended to driving the development and implementation of new verification testing protocols, tailored to meet each project's unique requirements. I also championed both internal and external audit preparations, which played a crucial role in enhancing our laboratory practices and ensuring compliance with enforced documentation standards and good laboratory practice (GLP).Through these initiatives, I not only achieved savings per device by directing a cost-reduction strategy for a PCB design project but also secured the integrity and safety of our medical devices, proving my dedication to excellence and innovation in healthcare technology.