Senior Development Engineer

Intersurgical Medical Sdn Bhd; Seberang Perai; On-site; MYR 200,000 - 250,000; Full time

Job summary

A medical device company in Penang is seeking a Senior Development Engineer. The successful candidate will lead product development efforts, mentor junior staff, and ensure compliance with industry standards. Applicants should have a Bachelor's in engineering and at least six years of experience, particularly in medical device environments. Competitive salary and comprehensive benefits are offered in a supportive team environment.

Benefits

Competitive salary package

Annual performance review

Group insurance plan

Qualifications

• Minimum of six years of experience in research and development.
• Experience in medical device manufacturing is ideal.
• Strong problem-solving skills and attention to detail.

Responsibilities

• Lead the research, design and development of new products.
• Train junior engineers in design and development.
• Carry out material selection and prototyping.

Skills

Design controls

3D modelling (SolidWorks)

Risk management

Tolerance stack up analysis

Injection moulding

Education

Bachelor's degree in engineering

Tools

SolidWorks

Job description

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As a Senior Development Engineer, you will be responsible for driving development of new products, engineering change, testing and validation, risk management and handover of projects into production.

Qualifications & experience:

Education or Competency Requirement: Bachelor's degree in an engineering discipline or equivalent. Preferably specialises in Mechanical Engineering, Materials Engineering or Polymer Engineering.

Experience: A minimum of six (6) years of relevant experience covering research and development and new product introduction, ideally within the medical device manufacturing environment.

Strong knowledge on design controls, product and development specifically related to plastic parts, process knowledge on injection moulding, extrusion or assembly processes, drawings and 3D modelling (SolidWorks), risk management and validation.

Proficiency in tolerance stack up analysis or mould design would be added advantage.

Key Responsibilities:

Lead the research, design and development of new products.

Train and guide junior engineers and technicians in design and development related topics.

Carry out material selection, prototyping or feasibility studies.

Source, select and develop suppliers to support design and development work.

Generate and maintain product and design documentation such as product specifications, 2D drawings and 3D models, tolerance stack up analysis, Bill of Materials and more.

Participate in mould design for manufacturability review, mould trials and qualification activities.

Drive test development, design verification activities and stability studies.

Support validation activities.

Perform failure analysis and risk management activities.

Identify and drive continuous improvement and engineering change efforts.

Create and maintain design history file and device master record.

Additional Requirements:

Detail oriented, analytical, critical and have strong problem-solving skills.

Excellent communication and team collaboration abilities.

ably have ISO 13485 and FDA 21 CFR 820 training or exposure.

Competitive salary package

Annual performance and salary review

Enjoy a familial company atmosphere

Group insurance plan and medical expense claim

Unlock job insights

Your application will include the following questions:

• What's your expected monthly basic salary?
• Which of the following types of qualifications do you have?
• Which of the following languages are you fluent in?
• How much notice are you required to give your current employer?
• How would you rate your English language skills?
• How many years' experience do you have as a Process Development Engineer?
• Do you have experience working within a lean agile team?
• How many years' experience do you have as a research & development engineer?

What can I earn as a Development Engineer