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NPI Engineer

1/11/2026

The NPI Engineer will have technical responsibility for the product's DMR and oversee the transfer from development to production. They will also lead projects aimed at improving yield, reliability, and cost efficiency.

Working Hours

40 hours/week

Company Size

11-50 employees

Language

English

Visa Sponsorship

About The Company

Pi-Cardia is a medical device company and market leader in the development of a broad portfolio of leaflet modification solutions for treating heart valves. The company has years of knowledge and expertise accumulated in degenerated valves, including calcification patterns, mode of valve failure, and impact of various methods of leaflet modification. ShortCut™ is designed to provide a safe, simple, and effective way to split leaflets of a pre-existing valve to enable TAVR in patients at risk for coronary obstruction and may assist in preserving coronary access.

About the Role

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.

Key Skills

NPI EngineeringManufacturing ProcessesProblem-SolvingRisk-Based Decision MakingSolidWorksTeam PlayerContinuous ImprovementMedical DevicesClass 2/3 Medical Device TransferHands OnYield ImprovementReliability IncreaseCost ReductionSupplier ManagementSubcontractor ManagementPFMEA