Staff NPI Engineer (Medical Device)

Location: On-site in Gelang Patah, Johor, supporting hirify.global Malaysia's manufacturing facility in Johor Bahru.

Company

hirify.global develops medical devices, including the OmniPod Insulin Management System and delivery platforms for subcutaneous drugs.

What you will do

• Lead New Product Introduction programs, product transfers, engineering projects, manufacturing readiness, production ramp-up, and sustaining support.
• Plan and coordinate engineering builds, Design Verification Builds, equipment qualifications, process validations, and implementation activities.
• Lead IQ/OQ/PQ execution and validation documentation.
• Provide technical leadership, coaching, and mentoring to engineers and technicians.
• Collaborate with Operations, Quality, Manufacturing Engineering, R&D, Supply Chain, and external suppliers.
• Drive continuous improvement, corrective and preventive actions, risk mitigation, quality, yield, equipment performance, and operational efficiency.

Requirements

• Bachelor's degree and 8+ years of medical device experience, preferably in Mechanical, Electrical, or Industrial Engineering.
• Strong project management experience leading cross-functional NPI, technology transfer, equipment qualification, and process validation projects.
• Experience with IQ/OQ/PQ execution and validation documentation.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, cGMP, and risk management methodologies including PFMEA.
• Excellent understanding of structured problem-solving tools such as DMAIC and Six Sigma Green Belt.
• Fluency in English and Mandarin is required.
• Experience working on a high-volume manufacturing line in a cleanroom environment is required.
• Ability to work off shifts, including nights or weekends, as needed, up to 10%.

Nice to have

• Familiarity with cGMP, ISO 13485, and FDA 21 CFR Part 820 requirements.
• Experience in fast-paced, high-volume manufacturing environments.
• Strong decision-making, communication, structured problem-solving, planning, prioritization, and organizational skills.
• Demonstrated initiative, accountability, ownership, and ability to drive issues to resolution.

Culture & Benefits

• On-site office, plant, and laboratory work is required.
• Work supports the start-up and ongoing operation of a new manufacturing facility.
• Role operates in a cGMP-compliant environment governed by FDA, ISO 13485, and company Quality System requirements.
• Up to 10% off-shift work may be required.