Full-Time
Systems/Risk Engineer
EROS Technologies
No salary listed
Highland Park, IL, USA
In Person
Category
 Biology & Biotech (1) |
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Requirements
- Bachelor's degree (Mechanical Engineering preferred)
- Experience in working in Medical devices and knowledge in medical quality process
- 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.)
- 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.)
- Excellent written and verbal communication is a must.
Desired Qualifications
- Proficiency in DOORS is preferred