About the role
AI summarisedThe Engineer 2, Process Development role supports new product introduction and production engineering in a regulated, high-volume environment. The position focuses on developing manufacturing solutions, driving process improvements, conducting failure analysis, and collaborating across R&D, design, test, and manufacturing teams to ensure product quality and yield. Responsibilities include DFM development, root cause analysis, and process optimization using engineering tools and methodologies.
BiotechOnsite
Key Responsibilities
- Work closely with R&D to develop Design-for-Manufacturing (DFM) processes for NPI, leveraging learning from existing products and providing feedback on material component selection and associated test plans
- Provides advanced failure analysis, root cause identification and corrective actions for product quality concerns and/or issues during manufacturing and NPI ramp
- Analyzes field quality data to identify areas for prevention and improved detection
- Proactively drives process improvement activities through FMEA to ascertain and recommend improvement to processes or test methods
Requirements
- Bachelor's Degree or Master's Degree in Engineering/Science in Chemistry, Mechanical, Electrical, Biomedical, Material or a related field
- Minimum 2 years of work experience, preferably in the biotech industry
- Experience in FDA-regulated environment is a plus
- Knowledge about wafer fabrication, biochemistry process, plastic engineering, or CMO Management will be an added advantage
- Possess good understanding of manufacturing processes, methodologies and environment
- Capable of defining test plans for components, materials and systems
- Skilled in failure analysis of multiple reliability failure modes
- Excellent Analytical, Problem Solving and Project Management skills
- Good understanding of Quality Assurance and Process Control Knowledge
- Excellent team player, interpersonal and communication skills
- Able to work well under stress, both internally and across functions and perform multitasking
- Proactive, innovative and self-motivating