NPI Engineer for Medical Device (ISO 13485 & GMP- CAD skill)

Company background: Multinational company- Medical Device

• Location: Telok Gong, 42000 Klang, Selangor

Flexi working hour of 8 hour daily according to individual schedule, from Monday Friday (between 7am 5pm)

• Attractive benefits:

Good Basic Salary based on experience

Working with stable & well-established company

Strategic location safe environment

Attendance Allowance

Performance Bonus and Annual Increment

Medical Benefits and Group Insurance Coverage

Long Term Service Award

Birthday Gift for employees

Career Advancement Opportunities

Key Responsibilities:

• Managing NPI project based on customer requests.

Evaluate and manage customer/supplier change request and converting the customer request into internal specification.

• Develop specification of new product according to customer requirements.

Establish the specification for new product, sustaining changes and raw material.

• Design, establish, validate, and implement new manufacturing process (automated, semi-automated and manual).

Design tools/die/jig/fixture for manufacturing process

• Prepare the Bill of Material for new material.

Assist in process cycle time calculation and line balance for new manufacturing line.

• Establish new test method for raw material and product inspection

Prepare required documentations & work procedures for manufacturing of new products / processes

• Support to technical challenges from daily operation.

Assist in validation and process improvement activities in production

• Provide training to production staff for new process implementation

Requirement:

• Degree/Post Graduate level education in Engineering or Science

Minimum 2-4 years working experience preferably in manufacturing or medical industry

• Good knowledge in Project Management & Process/Product development.

Familiar with CAD drawing/Solidworks

• Knowledge in statistical analysis

Knowledge of ISO 13485 and GMP is an advantage.

• Proactive and willing to learn

Good written and spoken English and Bahasa Malaysia.

• Computer skill familiar with Microsoft Office.

Job Type: Permanent

Pay: RM4,

• 00 - RM7,500.00 per month
  
  Benefits:
• Dental insurance

Flexible schedule

• Health insurance

Opportunities for promotion

• Professional development

Vision insurance
Schedule:

• Monday to Friday

Supplemental pay types:

• Attendance bonus

Performance bonus

• Yearly bonus

Experience:

* pharmaceutical , Biotechnology or Medical Device: 2 years (Required)