Erostechnologies Inc

Full Time - Systems/Risk Engineer

Full-time · Lake Forest, IL

✓ Verified live on the employer's own system · added 3780 days ago

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Skills & tools

Hazard AnalysisCommunications

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Full job description

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

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

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

Owns content of all Design Input Documents / product requirement

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.

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This posting was published by Erostechnologies Inc on their own careers system and is shown here with a direct link to apply there. Employers: for corrections or removal, contact jobs@veritahire.com.