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.