Medical Device Systems & Risk Engineer

EROS Technologies Inc.; Lake Forest (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading technology firm in Lake Forest seeks a Mechanical Engineer to manage product design and compliance in medical device development. Candidates must hold a degree in Mechanical Engineering and possess experience in medical quality processes along with familiarity with standards like 21CFR820. Your role will encompass managing design inputs and risk assessments to ensure compliance and safety in products. Strong communication skills and knowledge of DFMEA are essential for success in this position.

Qualifications

• Bachelor's degree in Mechanical Engineering preferred.
• Experience in working in Medical devices is necessary.
• Knowledge in medical quality processes is required.
• Familiarity with change control processes is essential.
• Experienced in 21CFR820 compliant environments.

Responsibilities

• Owns all Design Input Documents and product requirements.
• Generates the master trace matrix document.
• Traces requirements from specifications to verification.
• Allocates product requirements to subsystem specifications.
• Manages risk-related documents such as Hazard Analysis.

Skills

Communication

Risk Analysis

Experience in Medical Devices

DFMEA / DFMECA

Proficiency in DOORS

Education

Bachelor's degree in Mechanical Engineering

Tools

DOORS

Job description

A leading technology firm in Lake Forest seeks a Mechanical Engineer to manage product design and compliance in medical device development. Candidates must hold a degree in Mechanical Engineering and possess experience in medical quality processes along with familiarity with standards like 21CFR820. Your role will encompass managing design inputs and risk assessments to ensure compliance and safety in products. Strong communication skills and knowledge of DFMEA are essential for success in this position.