Systems Engineer

Overview

Remote
Depends on Experience
Contract - W2
Contract - 14 Month(s)

Skills

Design Controls
Requirements Management
Requirements Traceability
Systems Engineering
Jama

Job Details

We re seeking a Senior Design Engineer with strong Systems Engineering and Requirements Management experience to support development of implant and instrument design controls within a medical device environment.

Responsibilities:

  • Develop and implement systems engineering processes for design control and risk management.

  • Create and maintain architecture documents, trace matrices, and requirements hierarchies.

  • Work with Jama Connect (or similar tools like DOORS / Polarion) for requirements traceability.

  • Support verification and validation activities and contribute to product risk management.

  • Translate legacy requirements into a modern, model-based systems structure.

  • Ensure compliance with ISO 13485, ISO 14971, and FDA design control regulations.

Required Skills:

  • 2+ years experience in Systems Engineering, Design Control, or R&D within medical devices.

  • Hands-on experience with Requirements Management Tools (Jama Connect preferred).

  • Strong understanding of verification, validation, and traceability practices.

  • Knowledge of risk management and regulatory compliance (ISO 13485 / 14971).

  • Degree in Mechanical, Systems, Electrical, or Biomedical Engineering.

Nice to Have:

  • INCOSE ASEP or equivalent certification.

  • Experience with MBSE / SysML tools and Model-Based Systems Engineering.

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