Medical Device Systems Engineer (W2 Only)

Job Title: Systems Design / Product Development Engineer (Medical Device / SaMD)

Location: Remote (Must be available during Mountain Time hours) | Preferred: Salt Lake City, UT
Duration: Contract

Job Summary

We are seeking an experienced Systems Design / Product Development Engineer to support the development and lifecycle management of a software-based medical device (SaMD). This role focuses heavily on Design History File (DHF) documentation, design controls, verification & validation (V&V), risk management, and cross-functional collaboration in a regulated medical device environment.

Key Responsibilities

• Create, update, and maintain DHF documentation including user needs, design inputs, system requirements, software requirements, traceability matrices, and risk files.
• Support design controls and regulatory documentation throughout the product lifecycle.
• Participate in risk management activities including FMEA and usability engineering.
• Develop, execute, and document Verification & Validation (V&V) protocols, test cases, and reports.
• Collaborate with Engineering, Quality, Regulatory, and Clinical teams to ensure compliance with FDA and quality system requirements.
• Support documentation remediation and design authority transfer activities.

Required Skills

• 5+ years of Systems Design, Systems Engineering, or Product Development experience in the medical device industry.
• Strong hands-on experience creating and maintaining Design History File (DHF) documentation.
• Experience with design controls, requirements management, traceability, and risk management.
• Knowledge of ISO 14971; familiarity with ISO 62304 and IEC 62366 is preferred.
• Experience in FDA-regulated/QMS environments.
• Experience drafting requirements, protocols, and executing V&V testing.
• Excellent communication and documentation skills.
• Experience with Codebeamer, JIRA, or similar requirements management tools is a plus.

Preferred Qualifications

• Experience with Software as a Medical Device (SaMD).
• Previous experience with Zimmer Biomet or Orthogrid projects is highly preferred.
• Biomedical Engineering background preferred.

Education

• Bachelor''''s degree in Engineering, Biomedical Engineering, or a related scientific discipline.

Must-Have Skills

• Systems Design / Product Development Engineering
• Design History File (DHF)
• Design Controls
• Requirements Management
• Verification & Validation (V&V)
• Risk Management / FMEA
• FDA-Regulated Medical Device Environment
• ISO 14971
• Requirements Traceability
• Strong Technical Documentation & Communication