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Manufacturing Engineer

2 months ago

George Town, Penang, Malaysia Link Compliance Full time
{"Job Title": "Manufacturing Engineer", "Job Description": "Job Summary

Link Compliance is seeking a highly skilled Manufacturing Engineer to join our team. As a key member of our team, you will be responsible for managing projects and overseeing day-to-day activities at our contract manufacturing facility. Your expertise in manufacturing engineering, project management, and quality assurance will be instrumental in driving on-time completion of activities and ensuring compliance with FDA and ISO quality system regulations.

Key Responsibilities
  1. Project Management: Develop and coordinate tactical plans with contract manufacturing technical staff, and regularly report status.
  2. Manufacturing Engineering: Interface with contract manufacturer and US-based engineering teams, representing company interests and bridging time differences.
  3. Quality Assurance: Read and understand, and support execution of test protocols, perform/oversee testing, and review or author reports to support test method validation (TMV), process validation (IQ, OQ, PQ), intended use validation (IUV), flowcharts, PFMEA, DOE, Gage R&R in accordance with FDA and ISO quality system regulations.
  4. Process Improvement: Analyze and recommend improvements to existing processes using Lean Manufacturing principles.
  5. Supplier Quality: Interface with Quality group to resolve Manufacturing related issues, using different quality tools such as 5whys, cause and effect diagram, etc. and problem-solving methodologies such as Six Sigma.
Requirements
  1. Bachelor's degree or higher in Mechanical/Manufacturing Engineering or related discipline.
  2. 2+ years of project management/manufacturing engineering experience in medical device industry supporting a FDA Class III medical device.
  3. Experience working with/in contract manufacturing environment.
  4. "Hands-on" mechanical aptitude, engineering acumen and analytical skills.
  5. Ability to read and understand engineering drawings.
  6. Process implementation and process validation experience.
  7. Experience with software-based mechanical medical devices and products.
  8. Solid organizational planning, communication skills, articulate, team player, dependable, able to work in a fast-paced environment with accuracy/efficiency.
"}