Mainz Brady Group
Software Engineer
Mainz Brady Group, Downers Grove, Illinois, United States, 60516
Job Title: Remediation Engineer (SaMD)
We are seeking a skilled Remediation Engineer with experience in Software as a Medical Device (SaMD) to join our team. You will lead remediation efforts to ensure compliance, safety, and effectiveness of medical software products. The ideal candidate will have a strong background in SaMD, regulatory requirements, and risk management, with the ability to identify and resolve issues across the product lifecycle.
Key Responsibilities:Lead remediation efforts for SaMD products to meet regulatory and compliance standards.Conduct gap analysis and risk assessments to identify issues in existing systems.Collaborate with cross-functional teams (quality, engineering, regulatory) to implement corrective actions.Ensure documentation and processes align with ISO 13485, FDA, and other relevant standards.Validate and verify software updates to ensure compliance with SaMD requirements.Qualifications:
Bachelor's degree in engineering, software development, or related field.3+ years of experience in SaMD development, remediation, or related fields.Strong knowledge of medical device regulations (FDA, ISO 13485, IEC 62304).Experience with risk management, quality systems, and validation processes.Excellent problem-solving and communication skills.
If you have a passion for improving healthcare through software and have experience in medical device remediation, we'd love to hear from you!
We are seeking a skilled Remediation Engineer with experience in Software as a Medical Device (SaMD) to join our team. You will lead remediation efforts to ensure compliance, safety, and effectiveness of medical software products. The ideal candidate will have a strong background in SaMD, regulatory requirements, and risk management, with the ability to identify and resolve issues across the product lifecycle.
Key Responsibilities:Lead remediation efforts for SaMD products to meet regulatory and compliance standards.Conduct gap analysis and risk assessments to identify issues in existing systems.Collaborate with cross-functional teams (quality, engineering, regulatory) to implement corrective actions.Ensure documentation and processes align with ISO 13485, FDA, and other relevant standards.Validate and verify software updates to ensure compliance with SaMD requirements.Qualifications:
Bachelor's degree in engineering, software development, or related field.3+ years of experience in SaMD development, remediation, or related fields.Strong knowledge of medical device regulations (FDA, ISO 13485, IEC 62304).Experience with risk management, quality systems, and validation processes.Excellent problem-solving and communication skills.
If you have a passion for improving healthcare through software and have experience in medical device remediation, we'd love to hear from you!