Manufacturing /Production Engineer

Responsibilities:

Responsibilities:

· Coordinate and execute the molding efforts on new program launches

· Conduct tooling Contract review, mold design review, mold trial review, project review meetings

· Develop and install new injection molding equipment and document all implementation processes for molded products.

· Provide documented procedures on buyoff on new/transfer molds prior to mass production release

· Analyze and monitor manufacturing processes and data, suggest improvements, and maintain optimization of equipment.

· Review, evaluate, and manage First Article Inspection Reports (FAIR).

· Coordinate injection molding process validation activities (IQ, OQ, PQ) for new components.

· Complete PQ reports transferring products into ongoing production.

· Assist with developing and implementing Quality Procedures, Standard Operating Procedures and other manufacturing-related documentation.

· Prepare requests for project funding and monitor spending against budget through the completion of the project.

· Support investigation of customer complaints and initiate action to prevent the recurrence of non-conformities related to the product, processes, or the quality system.

· Manage cost requests, establish manufacturing costs and equipment, and maintain knowledge of safety regulations for various processes.

· Provide support to develop plastic tools for injection molding equipment and root cause analysis for injection molding processes.

· Administer projects and recommend improvements to facilitate first-time quality.

· Perform regular investigations and ensure optimizations for projects.

· Coordinate molding trials for new programs, providing feedback for corrective actions to tooling engineering, molding and material suppliers.

Requirements

Requirements:

Bachelor/Master Degree in Plastics, Tooling, or Mechanical Engineering (or equivalent scientific qualification).

· 5+ years of relevant working experience in injection molding and plastic engineering is required, preferably in medical device molding.

· Experience in Design of Experiments (DoE), injection molding process validation (IQ, OQ, PQ), and scientific molding procedures, preferably of medical equipment/ devices.

· Experience in 3D CAD applications and interpretation of plastic injection molding simulation software tools (e. g. Moldflow or Moldex3D) is desired.

· Experience in project work, problem-solving techniques, analytical and structured approaches, and teamwork.

· Understanding and familiarity with ISO 13485, medical product quality standards and health & safety regulations

· Time management skills and the ability to delegate.

· A team player with ability to work under minimum supervision

Benefits

Benefit Update:

• 13 months bonus
  
• Performance bonus (subject to the yearly performance of the company and the individual employee)
  
• Medical Claim (RM60/claim; max 500/yr)
  
• Dental/Optical (RM300/yr)
  
• Insurance coverage (Hospitalization, Life, Personal Accident)
  
• Transport allowance
  
• Meal allowance
  
• Attendance Allowance
  
• Yearly 15 days public holidays
  
• Yearly min. 15 days annual leave