Product Lifecycle Process Expert

2 weeks ago

Singapore beBeeManufacturing Full time $1,070,000 - $1,525,000
Job Title: Manufacturing Process Lead

About the Role:

The Manufacturing Process Lead will be responsible for overseeing the development, optimization, and sustaining of manufacturing processes for high-volume production of life science consumables. This role involves managing technical interfaces with Contract Manufacturers, ensuring process validation and control, and maintaining compliance with quality and performance standards.

This position requires coordination with cross-functional teams including R&D, Quality, and Manufacturing to support new product introductions, implement process improvements, and resolve production issues.


Main Responsibilities:

  • Serve as the process owner for manufacturing processes at Contract Manufacturers for plastic cartridges, including precision injection molding, laser welding, ultrasonic welding, mechanical assembly, and fluidic functional test.
  • Define product specifications, process control indicators, test strategies, and supplier KPIs for disposable products.
  • Responsible for resolving manufacturing issues related to yield, quality, and throughput in a timely manner.
  • Continuously seek opportunities for improvement in yield, quality, and cost.
  • Collaborate with R&D, Manufacturing, and Quality to develop molding and assembly processes for new products and improve existing ones.
  • Lead technical and production teams to support pilot runs and define scale-up manufacturing strategies at contract manufacturers.

Requirements:

  • Strong background in precision plastics molding and assembly processes is required.
  • Proven track record in managing Contract Manufacturing (CM) to resolve manufacturing and customer issues.
  • Proficient in CAPA and structured problem-solving methodologies.
  • Skilled in applying statistical tools, including SPC, DOE, and process capability analysis (PPK, CPK).
  • Experience with product development lifecycle and project management is required.
  • Familiarity with design and qualification of manufacturing jigs and fixtures, equipment, and automation solutions.
  • Strong interdepartmental communication skills and documentation are required.
  • Exposure to digital technologies, such as data analytics, RPA, and AI applications.
  • Will to travel for supplier engagement and technical support.

Preferred Experience/Education/Skills:

  • Bachelor's degree in mechanical engineering, bioengineering, plastics engineering, materials science, or a related field.
  • 5–9 years of relevant experience in biotech or medical device manufacturing.
  • Proficiency in Solidworks or equivalent CAD tool.
  • Experience in regulated environments (e.g., ISO 13485, GMP) is beneficial.

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