Systems/Risk Engineer
Lake Forest, IL
Full Time
Job Description
•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,
Ishwar
Sr. Resource Professional
Contact: +1- 408 318 6754
EROS Technologies Inc.
16192 Coastal Highway
Lewes, DE- 19958
Bachelor's degree (Mechanical Engineering preferred)
All your information will be kept confidential according to EEO guidelines.
Job details are sourced from the employer's original posting.
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