Medical Device Process Engineer II – NPI & Validation

Jabil Circuit (Singapore) Pte Ltd; Singapore; Vor Ort; SGD 60.000 - 90.000; Vollzeit

Zusammenfassung

Jabil in Singapore seeks an engineer to own assigned manufacturing processes, drive yield improvement, and support NPI and transfer activities. You will lead validation efforts for medical device products and ensure compliance to quality systems.

The role requires hands-on experience with process optimization, validation (IQ/OQ/PQ), and data-driven improvements. Candidates with 3–5 years in manufacturing and medical device familiarity are preferred.

Qualifikationen

• Bachelor degree in an engineering discipline as listed.
• 3–5 years in manufacturing, process or industrial engineering.
• 1–2+ years in medical device/IVD manufacturing preferred.
• Experience supporting NPI transfer and validation activities.

Aufgaben

• Owns manufacturing processes and drives yield improvement.
• Supports NPI and manufacturing transfer and leads validation activities.
• Apply ISO 13485 and FDA 21 CFR Part 820 requirements in daily work.
• Lead continuous improvement using DMAIC, Kaizen and OEE initiatives.
• Perform validation activities and prepare release documentation.

Kenntnisse

Process optimization

NPI transfer

Validation

Quality compliance

Data-driven decision making

Ausbildung

Bachelor Degree in Mechanical, Manufacturing, Industrial, Biomedical, Mechatronics or related Engineering

3 to 5 years of manufacturing, process or industrial engineering experience

2+ years of medical device, healthcare or IVD manufacturing experience preferred

Experience supporting NPI transfer and validation activities

Tools

FMEA

Gauge R&R

Minitab

Jobbeschreibung

Jabil in Singapore seeks an engineer to own assigned manufacturing processes, drive yield improvement, and support NPI and transfer activities. You will lead validation efforts for medical device products and ensure compliance to quality systems.

The role requires hands-on experience with process optimization, validation (IQ/OQ/PQ), and data-driven improvements. Candidates with 3–5 years in manufacturing and medical device familiarity are preferred.