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.
• Willing to travel as part of routine job responsibilities.