Medical device development

1 week ago


Singapore JMEDTECH COATING TECHNOLOGIES PTE. LTD. Full time
Roles & Responsibilities

We are seeking an experienced Medical Device Development Engineer with a strong background in the development and commercialization of medical devices. The ideal candidate will have over 5 years of relevant experience and a proven track record in innovative product design, prototyping, testing, and regulatory compliance. This role will involve working within a multidisciplinary team to design and improve cutting-edge medical devices that meet stringent industry standards.

Key Responsibilities:
  • Product Development: Lead and participate in all phases of the medical device development lifecycle—from concept and design through to prototyping, testing, and commercialization.
  • Design & Innovation: Develop and refine designs for medical devices, ensuring functionality, safety, and compliance with regulatory standards.
  • Cross-functional Collaboration: Work closely with R&D, quality assurance, manufacturing, and clinical teams to integrate technical insights into product development.
  • Regulatory Compliance: Prepare and maintain thorough documentation to support regulatory submissions and ensure adherence to standards such as ISO 13485 and FDA requirements.
  • Problem Solving: Identify technical challenges during development and implement effective solutions to enhance product performance.
  • Testing & Validation: Design and execute testing protocols to validate device performance and safety.
  • Documentation: Create and manage detailed design documentation, technical reports, and project records.
Qualifications:
  • Education: Bachelor’s, Master’s, or Ph.D. in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field.
  • Experience: A minimum of 5 years in the development of medical devices, demonstrating hands-on experience in design, testing, and regulatory compliance.
  • Technical Expertise: Strong understanding of medical device design processes, prototyping, and quality assurance methodologies.
  • Regulatory Knowledge: Familiarity with industry standards and regulatory requirements (e.g., ISO 13485, FDA guidelines).
  • Analytical Skills: Excellent problem-solving abilities with strong analytical and project management skills.
  • Communication: Effective verbal and written communication skills, with experience in preparing technical documentation and reports.
  • Teamwork: Proven ability to work collaboratively in a dynamic, cross-functional team environment.

Tell employers what skills you have

Performance Testing
FDA
Regulatory Compliance
Analytical Skills
Level Design
Problem Solving
Artifactory
Biomedical Engineering
Medical Devices
Commercialization
Product Development
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