Mechanical Engineer (Medical Devices)

Location: Batu Kawan, Malaysia; work involves external contract manufacturing facilities across Penang, Southeast Asia, and APAC.

Company

hirify.global develops medical products including equipment and disposables.

What you will do

• Drive SCN, ECO, and SPN deliverables from the initial stage through closure and manufacturing implementation.
• Generate, review, reject, or approve SCN, CAF, ECO, DR, JST, protocols, and reports.
• Review, analyze, and update 2D and 3D mechanical drawings, BOMs, and manufacturing instructions in Agile.
• Collaborate with R&D, Quality, Sourcing, and contract manufacturers during NPI, design transfer, V&V, and mass production.
• Support manufacturing as the primary engineering focal point for yield, quality, and material availability challenges; troubleshoot issues independently or with cross-functional teams.
• Monitor hirify.global-owned tooling and fixtures at contract manufacturers and sub-tier suppliers, and document activities with data-driven precision.

Requirements

• Bachelor’s or master’s degree in Mechanical Engineering or an equivalent qualification.
• 1–4 years of experience in manufacturing, engineering, or an equivalent area.
• Familiarity with the Agile system and related methodologies.
• Proficiency in basic statistical tools and knowledge of Six Sigma and LEAN manufacturing principles.
• Proficiency in SolidWorks, GD&T, and tolerance stack-up analysis.
• Experience developing or producing products using die casting, injection molding, plastic extrusion, machining, or sheet metal processes.
• Understanding of medical device manufacturing standards and practices, including GMP, process validation and verification, DOE, FAI, IQ/OQ/PQ protocols and reports, SPC, and process capability analysis.

Culture & Benefits

• Full-time employment.
• Challenging and rewarding work environment.
• Diverse and dynamic workplace.
• Collaboration with internal and external cross-functional stakeholders across the APAC region.