Medical Device Innovation Leader
This role plays a pivotal part in high-impact, multi-year R&D programs, collaborating with experts in engineering, clinical evaluation, regulatory affairs, and manufacturing.
Lead the entire New Product Development lifecycle, from concept to verification, validation, and launch.
Manage and coordinate complex projects across global teams and stakeholders, fostering effective collaboration and communication.
Apply engineering expertise to drive problem-solving and technical excellence, ensuring the delivery of innovative medical devices.
Champion robust quality and risk management practices throughout development, adhering to ISO 13485, FDA 21 CFR 820, and EU MDR guidelines.
Embed strong quality and risk management principles into development processes, driving business success through technical excellence.
* Engineering background with proven leadership in medical device R&D.
* Experience with Class II or Class III medical devices is preferred.
* Strong understanding of design controls, regulatory pathways, and quality systems is required.
* Excellent communication and stakeholder management skills are essential.
* Passion for developing technologies that have a meaningful impact on patients' lives is crucial.