NPD Manager - Catheters

Responsibilities:

Drive the entire product development lifecycle, from concept generation and feasibility assessment to design, testing, and validation.

Ensure all NPD activities adhere to the medical industry standards, regulations, and quality guidelines per ISO13485

Lead, manage and inspire a multidisciplinary team of engineers, designers, and technicians to ensure effective execution of NPD projects.

Provide strong leadership and mentorship to the NPD engineering teams, fostering a collaborative and innovative work culture within the department.

Explore new technologies as new growth engine.

Lead DOE, POC, POP studies

NPD unit and Projects Budget management

Identify potential risks and uncertainties associated with product development and implement mitigation strategies to ensure project success

Requirements:

Bachelor's degree in Biomedical/Mechanical/Electronics engineering, sciences, or related field; advanced degree preferred.

Minimum of 5 years of experience in medical device NPD/PDP, with a focus on catheters and electrophysiology cardiac sensors.

Proven track record of successfully leading and managing complex NPD projects from concept to commercialization.

Strong understanding of medical device regulations (e.g., FDA, ISO13485) and quality management systems.

Experience in managing a development department in the medical Davis field

Proven ability to lead DOE, POC, POP studies

Methodological approach and ability to be agile where required.

Experience in Risk management

Ability to work effectively in a global environment and with different cultures including far-east /Asia, USA and Europe.

Understanding in the field of micro-assembly and sensors – an advantage.

Clinical understanding – an advantage

The job includes business travels abroad