Product Development Engineer

Job Summary

A company is looking for a Product Development Engineer.

Key Responsibilities

• Refine existing product documentation and ensure regulatory compliance
• Draft and maintain design history file (DHF) content and support risk analysis
• Collaborate with cross-functional teams to define testable requirements and support V&V protocol development

Required Qualifications

• 5+ years of experience in system design within a multi-disciplinary organization
• Experience with software as a medical device (SaMD) concepts
• Familiarity with ISO 14971 and IEC 62366
• Bachelor's degree in engineering or a science-related field; biomedical engineering preferred
• Experience in a regulatory environment with strict compliance