Full Time - 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

EROS Technologies was founded with a simple motive of offering the clients exactly what they want, how they want and when they want it. By leveraging for its clients its technological edge and right-sourcing advantage, EROS in a short period of time has grown to become one of the most trusted strategic technology partners. Treating every client as the top priority, we customize our solutions and services to align with the unique needs of each client.

Job Description

Lake Forest, IL

Full Time

• 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: [phone]
Lewes, DE- 19958

Qualifications

Bachelor's degree (Mechanical Engineering preferred)

Additional Information

All your information will be kept confidential according to EEO guidelines.