Product Development Engineer

at  HERAEUS MEDICAL COMPONENTS SINGAPORE PTE LTD

PROCESS DEVELOPMENT:

• Develop and optimize robust manufacturing processes to achieve quality, cost, and efficiency targets.
• Implement process improvements and control mechanisms to enhance production stability.

KNOWLEDGE:

. Knowledge of IQ, PQ and validation processes for medical devices is an advantage.
. Knowledge of any statistical software such as Minitab for data analysis and interpretation
. Knowledge of troubleshooting, failure analysis, root cause analysis, issues closure and corrective action processes as required

. Proficient in engineering tools such as statistical analysis, design of experiments, product, and process capability analysis.

• Knowledge of machine troubleshooting and diagnosis is a plus.

SKILLS:

• Communication and presentation skills
• Project management skills
• Hands on experience needed in the test method design and process verification activities.
• Proficient in Microsoft Office.
  . Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.

QUALIFICATIONS

• Bachelor’s degree in engineering or a related technical field.
• Minimum 3-5 years of relevant working experience in a manufacturing environment in medical devices or equivalent environment.
• Strong understanding of manufacturing processes and mechanical system design.
• Familiar with Lean manufacturing techniques, and techniques such as FMEA, SPC and DOE methodologies.
• Familiar with ERP system and ISO 13485 requirements.
• Experience with CAD software such as SolidWorks for design of mechanical fixtures and tooling for the production equipment and project management tools such as MS Project or any for project planning and tracking.
• Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint) is required.