Product Development EngineerVirtualVocations • Irvine, California, United States
Product Development Engineer
VirtualVocations • Irvine, California, United States
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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
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