Peshala Kariawasam Email & Phone Number | I have 10 years of engineering experience across V&V, systems engineering and system safety roles in the medical devices and defence sectors. Through these roles I have developed the following skills: • Writing requirements: input, system, sub-system, interface, risk controls/safety requirements • Requirements and risk control/safety requirement traceability using tools such as DOORS and JAMA • Risk Analysis/Safety Assurance (System Risk Analysis (Hazards Analysis), FMEAs) for product development using AFAP and SFAIRP methodologies • Risk Assessments for manufacturing, field, development and verification issues • Conducting risk/hazard workshops involving multiple stakeholders and developing hazard log and safety case/safety assurance report • Regression analyses/plans for design changes and enhancements • Verification plans/protocols/reports and documentation for regulatory submissions • Design change control, design reviews, technical reviews and development issue handling • Strong knowledge of medical device product development process, quality management systems, regulatory audits for design and development process, document deliverables, standards compliance/certification process

Peshala Kariawasam

I have 10 years of engineering experience across V&V, systems engineering and system safety roles in...
Kellyville, New South Wales, Australia

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Peshala Kariawasam’s Location Kellyville, New South Wales, Australia

Peshala Kariawasam’s Current Industry Anomolous

Peshala Kariawasam’s Prior Industry The Iq Group Global | Resmed

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Associate Director | Principal System Safety Engineer

2023-12-01 00:00:00 - Present

Lead Systems Engineer

2020-03-01 00:00:00 - 2020-05-01 00:00:00

Senior Systems Engineer (Product Development)

2019-02-01 00:00:00 - 2020-03-01 00:00:00

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Peshala Kariawasam is a I have 10 years of engineering experience across V&V, systems engineering and system safety roles in the medical devices and defence sectors. Through these roles I have developed the following skills: • Writing requirements: input, system, sub-system, interface, risk controls/safety requirements • Requirements and risk control/safety requirement traceability using tools such as DOORS and JAMA • Risk Analysis/Safety Assurance (System Risk Analysis (Hazards Analysis), FMEAs) for product development using AFAP and SFAIRP methodologies • Risk Assessments for manufacturing, field, development and verification issues • Conducting risk/hazard workshops involving multiple stakeholders and developing hazard log and safety case/safety assurance report • Regression analyses/plans for design changes and enhancements • Verification plans/protocols/reports and documentation for regulatory submissions • Design change control, design reviews, technical reviews and development issue handling • Strong knowledge of medical device product development process, quality management systems, regulatory audits for design and development process, document deliverables, standards compliance/certification process