Engineering NPI Specialist MEDICAL DEVUCE

Responsibilities

System-Level Ownership

Deeply understand the architecture, function, and integration of both analyzer instruments and disposable cartridges, ensuring system-level manufacturability and reliability.

Participate in design reviews and risk assessments, providing actionable feedback to R&D on DFM (Design for Manufacturability) and DFA (Design for Assembly) for complex opto-mechanical and microfluidic disposable systems.

Manufacturing Process Analysis & Optimization

Map and analyze the entire production process, from incoming inspection and logistics through assembly, in-process testing, final QC, and packaging.

Evaluate the impact of design changes on yield, scrap rates, labor, tooling, supply chain, and regulatory compliance.

Lead root-cause investigations for manufacturing issues, collaborating with cross-functional teams to implement corrective actions.

Cross-Functional Collaboration

Serve as a vital link between Engineering, R&D, QA, Supply Chain, and Production, ensuring alignment and rapid resolution of issues.

Develop and maintain clear, precise documentation for manufacturing processes, test protocols, and change management.

Train production staff on new processes and technologies, ensuring knowledge transfer and process robustness.

Continuous Improvement & Cost Control

Identify and drive initiatives to reduce costs, improve yield, and enhance product quality without compromising compliance.

Monitor and report on key NPI metrics, using data to inform decision-making and continuous improvement.

Qualifications

Bachelor’s degree in Biomedical, Mechanical or Systems Engineering (or related field).

1+ years of hands-on experience in NPI, manufacturing engineering, or process development, ideally in the medical device or diagnostics industry.

Demonstrated ability to work with complex systems (electromechanical, fluidic, or optical) at both module and system levels.

Exceptional analytical skills with a proven track record of evaluating and improving manufacturing processes.

Excellent English communication skills (verbal and written), including technical documentation and cross-functional teamwork.

Strong hands-on skills—comfortable troubleshooting, assembling, and testing intricate devices.

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