NPI Engineer

Pi-Cardia, a dynamic medical device startup specializing in cardiovascular innovations, is looking for a NPI Engineer to join our team. This position holds technical responsibility for the product’s DMR, manufacturing processes, and production-related equipment, jigs, and tools. The role includes managing the transfer from development to production and leading continuous improvement projects aimed at enhancing yield, reliability, and cost efficiency. Responsibilities: Technical (engineering) responsibility for the product DMR Technical responsibility for manufacturing transfer from development to production Overall responsibility for manufacturing-related equipment, jigs, and tools Overall responsibility for manufacturing processes and PFMEA Overall responsibility for supplier and subcontractor of the product components Leading projects to improve yield, increase reliability and reduce cost.

Requirements: B.Sc. in Mechanical Engineering – Must. Experience: At least 2 years of experience as an NPI engineer in medical devices company or 2 years of experience as an NPI engineer + 4 years of experience in the medical device field Experience in transferring to manufacturing of class 2/3 medical device- An advantage. Strong problem-solving skills with a risk-based decision-making approach Experience with SolidWorks Hands On Team Player Ability to thrive in a fast-paced environment, lead changes, and constantly strives for continuous improvement within the department and process.