NPI Specialist MEDICAL device (mechanical engineer)

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.