Engineer Teknis R & D 研发技术工程师

PT Vitanova Medical Indonesia; Desa Ciranjeng; Sur place; IDR 180 000 000 - 360 000 000; Plein temps

Résumé du poste

PT Vitanova Medical Indonesia is seeking an R&D Technical Engineer to support the research, development, design, and lifecycle management of disposable medical device products. You will work closely with Quality, Production, and Regulatory Affairs to ensure quality and regulatory compliance.

You should understand ISO 13485; the role involves product research, development, testing, documentation, and cross-functional coordination to drive improvements and technical problem solving across the

Qualifications

• Bachelor's degree or above in Engineering, Biomedical Engineering, Polymer, Chemical Engineering
• Strong cross-functional communication and coordination skills
• Detail-oriented and able to work under audit and regulatory pressure
• Capable of working independently as well as collaboratively within a team

Responsabilités

• Lead product research and development of disposable medical device products following regulatory and quality requirements
• Participate in design, development, verification and validation through production implementation
• Analyze and resolve technical issues during development and trial production
• Collaborate with Quality, Production and Regulatory Affairs on product and process matters
• Prepare, review and maintain technical documentation and reports

Connaissances

Cross-functional communication

Detail-oriented

Regulatory awareness

Independent & teamwork

Formation

Engineering (Bachelor's or above)

Biomedical Engineering

Polymer Engineering

Chemical Engineering

Description du poste

We are looking for an R&D Technical Engineer to support the research, development, design, improvement, and technical management of disposable medical device products.

The role will be responsible for supporting product development and improvement activities throughout the product lifecycle, working closely with Quality, Production, and Regulatory Affairs teams to ensure product quality, compliance, and effective implementation of technical requirements. Understanding of ISO 13485 and other ISO certification requirement will be a bonus point.

Key Responsibilities

1. Product Research & Development

Manage and execute the development and design process of disposable medical device products in accordance with applicable regulatory and quality requirements.

Participate in product development activities from concept, design, development, verification and validation through production implementation.

Conduct product and process trials, testing, evaluation, and technical analysis.

Identify, analyze, and resolve technical issues during product development and trial production.

Evaluate materials, processing methods, production equipment, molds, and tooling related to product development.

Prepare and maintain product development-related technical documentation.

2. Product Lifecycle Management

Support the full lifecycle management of medical device products, from design and validation through production and post-market activities.

Maintain product technical information and development records throughout the product lifecycle.

Participate in product improvement and engineering change activities.

Support product risk management and related technical activities.

Follow up on technical issues and improvement actions throughout the product lifecycle.

3. Product Improvement & Technical Support

Analyze and improve existing products and production processes to enhance product quality, process stability, and production efficiency.

Understand and apply polymer/material processing characteristics in product development and process improvement.

Provide basic technical support for relevant production equipment and processes.

Conduct technical analysis and root cause investigation for product or process abnormalities.

Provide technical support and solutions to Production and Quality teams.

Support implementation and follow-up of technical improvement activities.

4. Cross-Functional Collaboration

Work closely with Quality, Production, and Regulatory Affairs departments on product and process-related matters.

Clearly explain technical concepts, analysis, and technical logic to non-technical stakeholders using accessible language.

Coordinate cross-functional activities to ensure effective implementation of technical requirements.

Support resolution of cross-functional issues, particularly when balancing production efficiency with product quality and regulatory requirements.

5. Technical Documentation

Prepare, compile, review, and maintain professional technical documentation, including:

Technical reports

Verification and validation documents

Technical investigation and analysis reports

Relevant procedures and technical records

Ensure technical documents are accurate, systematic, traceable, and properly maintained.

Qualifications

Bachelor's degree or above in Engineering, Biomedical Engineering, Polymer, Chemical Engineering, or related disciplines.

Strong cross-functional communication and coordination skills.

Detail-oriented, systematic, and able to work under audit and regulatory pressure.

Capable of working independently as well as collaboratively within a team.