Lead Risk Engineer, Medical Devices

Vantive

Hinoba-an

On-site

PHP 900,000 - 1,500,000

Full time

5 days ago

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Job summary

Vantive is advancing vital organ therapies by delivering digital solutions and services to care teams and patients worldwide. This role provides technical leadership in Risk Management for Device Engineering, guiding RM activities from development through post-market stages and collaborating with cross-functional teams to ensure product safety and effectiveness.

You will drive risk analysis, define verification and validation needs, and align with IEC/ISO standards while advocating for

Qualifications

Bachelor or Master in Engineering with 7–10 years in electromechanical medical device design.
Experience leading Risk Management for medical devices and design controls.
Knowledge of ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, IEEE-1633.
Six Sigma Green/Black Belt or LEAN certification preferred.

Responsibilities

Lead Risk Management activities for products across the lifecycle from development to post-market surveillance.
Provide ongoing risk analysis and identify required risk mitigations to ensure safe, effective products.
Define requirements and verification/validation testing to mitigate risk.
Drive completion of Risk Management activities towards design transfer and commercialization.
Provide leadership and SME guidance to ensure RM principles are applied throughout development.
Create and approve Design History File deliverables related to Risk Management.
Assess and improve RM processes and interrelationships with Reliability.