Senior / Engineer, Innovation, Medical Technology Office

KK Women's & Children's Hospital; Singapore; On-site; SGD 50,000 - 80,000; Full time

Job summary

A leading healthcare institution in Singapore is looking for a professional to assist in identifying clinical needs and managing med-tech innovation projects. The ideal candidate holds a relevant degree with experience in product development, strong problem-solving abilities, and knowledge in regulatory standards. This role includes administrative support for innovation training and compliance documentation.

Qualifications

• Preferably 2 years’ experience in medical technology innovation.
• Strong knowledge in IT and CAD skills.
• Good knowledge in ISO 13485, ISO 14155, and GCP.

Responsibilities

• Assist in identification and validation of unmet clinical needs.
• Create supporting documentation for patenting and regulatory approval.
• Manage project tasks to ensure timely completion of milestones.

Skills

Teamwork

Communication skills

Problem solving

Technical writing

Education

Master’s/Bachelor’s Degree in Engineering or Biomedical Engineering

Tools

LabView

MatLab

SolidWorks

AutoCad

Job description

You will assist in the identification, validation and selection of unmet clinical needs, as well as participate in solution generation and prototyping. You will conduct testing, create supporting documentation required for patenting and regulatory approval and work with partners on commercialisation strategy.

You will coordinate and compile relevant information for grants and other funding applications, as well as manage and drive project tasks to ensure timely completion of project milestones. You will create relevant documentation, meeting records and support follow-up actions for clinical innovation projects.

You will support the device development team in brainstorming and prototype creation for projects. You will also be involved in general administrative and procurement assistance, and support the department in the program management of med-tech innovation grants including the grant application process, grant award and progress reporting.

You will provide administrative support for innovation training and education initiatives, including planning, implementation, publicity and events.

You will ensure compliance with quality, regulatory and organisation policies and systems, and support record-keeping and documentation needed for compliance.

Requirements

• Master’s / Bachelor’s Degree in Engineering, Biomedical Engineering or Science with preferably 2 years’ experience in medical technology innovation leading the development of concept ideas into products.
• Excellent team work and communication skills.
• Excellent problem solving skills with strong focus in technical writing.
• Strong knowledge in IT, CAD and/or Simulation Skills, e.g. LabView, MatLab, SolidWorks, AutoCad.
• Good knowledge in ISO 13485, ISO14155, Good Clinical Practice (GCP), Regulatory Affairs, Medical Device Standards, Intellectual Property Strategy will be an advantage.
• Knowledge of trial procedures, institutional, Centralised Institutional Review Board and regulatory authority (HSA) requirements will be an advantage.