Job Title: Systems Engineer

Job Description

The Systems Engineer will evaluate user needs and product requirements to organize documentation that accurately reflects previous testing. This role involves remediation work for current market products, releasing change orders based on document verification to update reports or traceability matrices.

Responsibilities

• Organize documentation to reflect previous testing results.
• Conduct remediation work for current products in the marketplace.
• Release change orders based on document verification.
• Update reports or traceability matrices.
• Use traceability matrix to identify documentation gaps and provide supporting evidence.
• Produce and release change orders to update documents.
• Understand design inputs and outputs related to user needs and 21 CFR Part 820 compliance.
• Execute verification tasks in alignment with design protocols.

Essential Skills

• Proficiency in traceability and change order processes.
• Experience with Quality Management Systems (QMS).
• Understanding of Design Input and Design Output.
• Familiarity with User Needs and 21 CFR Part 820.
• Ability to execute verification tasks and align them with design protocols.
• Experience using JAMA software.

Additional Skills & Qualifications

• Remediation experience.
• 5 years of experience in the medical device field, including biomed, electrical, or mechanical engineering.
• Experience with capital equipment with software preferred.
• Knowledge of IVD and implants acceptable.

Work Environment

The project is anticipated to end by December 2025, with the possibility of extension if needed. The team operates with the flexibility of a growth-focused company despite its large size. The company boasts a beautiful campus near a major stadium and is expanding with a new building.