- Singapore
Kerja Sepenuh Masa Senior Test Engineer – Design Verification - Validation (Medical Devices), Gaji tinggi SGD 5,500 di RECRUITPEDIA PTE. LTD. - Maukerja
Senior Test Engineer – Design Verification - Validation (Medical Devices)
RECRUITPEDIA PTE. LTD.
Kongsi
Simpan
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
Our client is a leading local medical device contract manufacturer specialising in the development and manufacturing of medical devices for global markets.
Working Days:
Monday – Friday
Working Hours:
8:00am – 5:30pm
Location:
East
Job Responsibilities
Develop and implement design verification strategies for medical device development projects.
Prepare verification plans, protocols, acceptance criteria and traceability documentation.
Lead test readiness reviews and ensure test protocols, equipment, fixtures and samples are properly prepared.
Develop, validate and execute test methods for design verification activities.
Design and develop clinically relevant test methods to verify product requirements.
Design, build, qualify and maintain electro-mechanical test fixtures, jigs, test benches and related equipment.
Conduct Installation Qualification (IQ) and Operational Qualification (OQ) for test fixtures and equipment.
Execute verification, feasibility, reliability, accelerated life and test-to-failure studies across mechanical, electrical and system-level requirements.
Analyse test data using appropriate statistical methods and prepare technical verification reports.
Ensure traceability from design inputs through verification protocols, test results and final reports.
Support regulatory submissions and maintain audit-ready technical documentation.
Collaborate with Mechanical, Electrical, Systems, Firmware, Quality, Regulatory and Manufacturing teams throughout product development.
Support risk assessments, design improvements and root cause investigations.
Ensure verification activities comply with applicable medical device quality and regulatory requirements.
Perform other duties as assigned.
Requirements
Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Mechatronics or a related discipline.
5–8 years of relevant experience in test engineering, design verification or Validation & Verification (V&V), preferably within the medical device industry.
Familiarity with
FDA 21 CFR 820.30(f), FDA 510(k), EU MDR, ISO 14971 and ISO 13485
.
Experience with design controls, risk management, traceability and audit-ready documentation.
Hands-on experience with test fixtures, electro-mechanical test equipment and test method validation.
Knowledge of CAD tools such as SolidWorks and statistical tools such as Minitab or JMP will be an advantage.
Experience with surgical, endoscopic, urological or minimally invasive medical devices will be an advantage.
Interested candidates who wish to apply for the advertised position are encouraged to click
"Apply Now"
to submit their application.
We regret that only shortlisted candidates will be notified.
Recruitpedia Pte. Ltd.
EA Licence No.: 19C9682
EA Registration No.: R23115655 (Michelle Yeo Swee Xiang)
RecruitPedia
is an innovative, efficacious recruitment solution provider headquartered in Singapore.
We are constantly expanding and our trained headhunting consultants are distinguished by their extensive international industry knowledge and experience. It will be our greatest honour to be able to guide you along the ever-changing job market and assist you step-by-step with any challenges you face along the way.
RecruitPedia
believes that all our clients and candidates deserve excellent service and strives to be the best and trusted service provider.
Working Days:
Monday – Friday
Working Hours:
8:00am – 5:30pm
Location:
East
Job Responsibilities
Develop and implement design verification strategies for medical device development projects.
Prepare verification plans, protocols, acceptance criteria and traceability documentation.
Lead test readiness reviews and ensure test protocols, equipment, fixtures and samples are properly prepared.
Develop, validate and execute test methods for design verification activities.
Design and develop clinically relevant test methods to verify product requirements.
Design, build, qualify and maintain electro-mechanical test fixtures, jigs, test benches and related equipment.
Conduct Installation Qualification (IQ) and Operational Qualification (OQ) for test fixtures and equipment.
Execute verification, feasibility, reliability, accelerated life and test-to-failure studies across mechanical, electrical and system-level requirements.
Analyse test data using appropriate statistical methods and prepare technical verification reports.
Ensure traceability from design inputs through verification protocols, test results and final reports.
Support regulatory submissions and maintain audit-ready technical documentation.
Collaborate with Mechanical, Electrical, Systems, Firmware, Quality, Regulatory and Manufacturing teams throughout product development.
Support risk assessments, design improvements and root cause investigations.
Ensure verification activities comply with applicable medical device quality and regulatory requirements.
Perform other duties as assigned.
Requirements
Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Mechatronics or a related discipline.
5–8 years of relevant experience in test engineering, design verification or Validation & Verification (V&V), preferably within the medical device industry.
Familiarity with
FDA 21 CFR 820.30(f), FDA 510(k), EU MDR, ISO 14971 and ISO 13485
.
Experience with design controls, risk management, traceability and audit-ready documentation.
Hands-on experience with test fixtures, electro-mechanical test equipment and test method validation.
Knowledge of CAD tools such as SolidWorks and statistical tools such as Minitab or JMP will be an advantage.
Experience with surgical, endoscopic, urological or minimally invasive medical devices will be an advantage.
Interested candidates who wish to apply for the advertised position are encouraged to click
"Apply Now"
to submit their application.
We regret that only shortlisted candidates will be notified.
Recruitpedia Pte. Ltd.
EA Licence No.: 19C9682
EA Registration No.: R23115655 (Michelle Yeo Swee Xiang)
RecruitPedia
is an innovative, efficacious recruitment solution provider headquartered in Singapore.
We are constantly expanding and our trained headhunting consultants are distinguished by their extensive international industry knowledge and experience. It will be our greatest honour to be able to guide you along the ever-changing job market and assist you step-by-step with any challenges you face along the way.
RecruitPedia
believes that all our clients and candidates deserve excellent service and strives to be the best and trusted service provider.
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