Engineering Manager

Job Responsibilities: -

Taking the necessary action to ensure that the standards related ISO 13485, GMP, product ISO standards and other regulatory requirements are achieved at all times.

Initiate/implement projects on new product and improvement /enhancement programmes on existing product in relation to: -

Technical Support to manufacturing and technical sales

New material investigation & evaluation

New customer technical support

Manufacturing process development

Validation and re-validation activities

Process verification activities

Machine downtime and performance of production equipment.

Process efficiency/process improvement

Preventative maintenance programmes of production equipment

Process Engineering projects are on time

Cost reduction programmes

Implementation of Lean Manufacturing

Evaluate competitor products when applicable to new development and keep up to date with current changes in technology.

Review and evaluate change requests from suppliers and customers.

Job Requirements: -

Candidate must possess at least a college Degree in Engineering / Science & Technology or equivalent with a thorough working knowledge of High Tech / Engineering principles essential.

At least three (3) years experience in project management / research & development preferably with experience in moulding, assembly and automation process.

Preferably with working experience in a manufacturing environment that is ISO 13485 certified.

Preferably with knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP.

Initiative, creativity, resourcefulness and ability to work independently are essential.

Good written and spoken English and Bahasa Melayu.

Computer literate.