Engineer - Medical

REPORTING TO

Manager Technical

SCOPE

• Performing electrical safety testing and evaluation on a variety of Medical Devices to the provisions of U.S., Canadian and other International product safety standards such as IEC /ANSI/CSA 60601-1 and its collateral and Particular standards and writing reports; and communicating with clients.

NO. OF REPORTEES

Individual Contributor Role

Responsibilities

Key Actions

SUCCESS FACTORS

Operations Excellence

• Responsible for performing test of products in accordance with applicable standards. Core tests include but are not limited to: Medical product Safety testing (IEC/ EN 60601-1 3.1 edition), Collateral Standards ( IEC 60601-1-X) and Performance Standards ( IEC 60601-2-X & IEC/ISO 80601-2-X).
• Test experience in Medical device testing and requirements are preferable.
• Knowledge on all Basic and product standards
• Responsible for preparing test plan for products containing different test parameters, relevant test method/standard & requirement / limit / acceptance criteria of each test.
• Ensure quality of service is maintained throughout the certification and inspection process
• Responsible for occupational safety and housekeeping
• Ensure quotes and commitment dates are and in line with team targets
• Assist in conducting audit time to time.
• Read and determine applicability of national codes and standards clauses for the EUT(equipment under test).
• Read and understand schematics and manufacturing instructions.
• Validate the project scope and sample applicability.
• Under scope of the project, identify and locate test instruments and equipment required for testing.
• Follow established test plan.
• Set up and operate EUT; perform and document simple repairs on EUT as needed.
• Conduct thorough construction review; document test results.
• Perform testing of products in accordance with applicable standards. Core tests include, but are not limited to: Power input or rating test, leakage current, dielectric, temperature, pressure, stability, mechanical hazard, flammability, abnormal and single faults, ingress protection Testing, rain, radiation, sound, laser etc.
• Knowledge of ISO 14971 and perform risk management review to IEC 60601-1, usability to IEC 60601-1-6 and 62366, software to IEC 62304 and other related process-based standard file reviews.
• Support Operations Manager/Business Head in routine activities.
• Maintaining TAT of Testing
• Quality of testing to be at par with defined standards

Stakeholder Management

• Provide technical assistance to clients and manage and resolve customer issues to ensure services delivered result in a high level of customer satisfaction
• Co-ordinate with third party test labs to get quotation, test slots & test reports
• Co-ordinate with INTERTEK overseas test labs to get quotation, test slots & test reports
• Travel to third party test lab to witness the safety testing
• Coordination with respective regulatory authorities.
• Ongoing coordination with support functions
• Tracking of NPS
• Consistent adherence to regulatory guidelines

We are Looking for You with

Qualification

Bachelor of Electrical/ Electronic Engineering

Technical Certifications

• Exposure to applicable testing and certification standards

Expertise at

• Exposure to applicable testing and certification standards.
• Should have an experience of testing multiple products

Behaviours & Aptitude

• Team player
• Strong verbal and written communication skills
• Strong presentation skills and confidence to deliver message to wide audience.
• Strong problem solving and organizational skills.
• Open to travel Domestic and International whenever required.