Product Development Engineer

A company is looking for a Product Development Engineer.

Key Responsibilities

Refine existing product documentation and ensure regulatory alignment

Support risk analysis and contribute to usability planning and design mitigations

Collaborate with R&D, QA, clinical, and regulatory functions to define testable requirements and support V&V protocol development

Required Qualifications

2-6 years of experience in system design and product development

Experience with drafting and maintaining design history file (DHF) content

Familiarity with ISO 14971 and experience with Software as a Medical Device (SaMD) products

Bachelor's degree in engineering or a science-related field; biomedical engineering preferred

Experience in a regulatory environment with strict compliance