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Medical Device Systems Design Engineer- SaMD and DHF

Remote • Posted 2 hours ago • Updated 1 hour ago

Contract W2

Remote

$40 - $50/hr

Fitment

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Job Details

Skills

DHF
SaMD
FDA/QMS
ISO 14971
R&D
IEC 62304
IEC 62366
Medical Devices

Summary

JOB DESCRIPTION:

We are seeking a Systems Design / Product Development Engineer to support the development of a Software as a Medical Device (SaMD) in a regulated medical device environment. This role focuses on creating and maintaining Design History File (DHF) documentation, supporting systems engineering, risk management, verification & validation (V&V), and ensuring compliance with FDA/QMS requirements throughout the product lifecycle.

Key Responsibilities:

Develop and maintain DHF documentation, including user needs, system/software requirements, design inputs, traceability matrices, and risk files.
Support risk management activities (ISO 14971), usability engineering, and V&V planning, execution, and reporting.
Collaborate with R&D, QA, Clinical, and Regulatory teams to ensure compliant product development.
Maintain requirements traceability using tools such as Codebeamer, JIRA, or similar platforms.

Required Qualifications:

Bachelor's degree in Engineering or a related field (Biomedical Engineering preferred).
5+ years of systems engineering or product development experience in a regulated medical device environment.
Hands-on experience with SaMD, DHF documentation, FDA/QMS, and ISO 14971.
Familiarity with IEC 62304, IEC 62366, and requirements management tools (Codebeamer/JIRA) is preferred.
Strong analytical, documentation, and cross-functional communication skills.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 90944144
Position Id: 9014494
Posted 2 hours ago

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Sumanth Parikh

Recruiter @ Synkriom

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Medical Device Systems Design Engineer- SaMD and DHF

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Sumanth Parikh

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