Full Time - Systems/Risk Engineer

• Bachelor's degree (Mechanical Engineering preferred)

• Experience in working in Medical devices and knowledge in medical quality process

• Should have worked in medical new product development projects & sustenance projects

• Experience in change control process

• Should have worked in 21CFR820 (design control processes) compliant environment.

• Owns content of all Design Input Documents / product requirement

• Owns the generation of the master trace matrix document

• Owns tracing at all levels of the requirements flow down from requirements to risk and then to design output & verification

• Owns allocation of product requirements to subsystem level specifications

• Should have basic knowledge on Risk related documents (Hazard Analysis, User Error risk analysis, Compliant code mapping etc.)

• Should have exposure to manufacturing processes of plastic and glass components.

• Should be able to own and execute DFMEA / DFMECA for disposables (IV Administration sets, syringes, etc.).
• Proficiency in DOORS is preferred.
• Excellent written and verbal communication is a must.

Regards,

EROS Technologies Inc.

All your information will be kept confidential according to EEO guidelines.