Junior Engineer / Engineer II

We are seeking a Junior Engineer / Engineer II to apply engineering and technical skills to support the development, improvement, and maintenance of medical devices and combination products. In this role, you will contribute to the creation and upkeep of Design History File (DHF) documentation and support compliance with 21 CFR 820.30 Design Controls and ISO 14971 Risk Management.

You will collaborate with cross-functional partners to research requirements, support design verification and validation activities, contribute to human factors assessments, and help maintain DHF and risk management deliverables that ensure the safety and efficacy of new and existing products.

Responsibilities

As a Junior Engineer / Engineer II, you will support new product development and the remediation/maintenance of existing product lines by assisting with the creation, management, and analysis of DHF documentation, product risk management files, and associated engine...