Michael Page US
Principal Quality Software Engineer- Med Device- Greater Boston
Michael Page US, Boston, Massachusetts, us, 02298
Job Responsibilities
Act as the representative during all phases of product development, including design, verification, validation, transfer, and design reviews.Participate in risk management activities, ensuring comprehensive analysis and documentation throughout the product development lifecycle.Provide support to design teams for software, hardware, and data science during the design control process and Software Development Life Cycle (SDLC).Support sustaining engineering efforts through activities like material control, process improvement, inspections, nonconforming material management, equipment qualification, and supplier oversight.Perform inspections and testing of materials, equipment, processes, and products to ensure compliance with quality specifications.Develop and implement quality system processes to meet regulatory requirements.Conduct cross-functional training on quality and compliance best practices and mentor members of the QA team.Assist in internal audit processes and ensure readiness for external ISO 13485 certification.Stay updated on external standards to enhance compliance efforts in preparation for product commercialization.Minimum Requirements
Bachelor's degree in mechanical, biomedical, or a related engineering discipline.Minimum of 8 years of experience in quality engineering or a similar position within a regulated industry.Background in software, data science, hardware/systems design, or medical device development within a Quality Management System.Strong understanding of regulations such as 21 CFR 820, ISO 13485:2016, and IEC 62304:2006.Hands-on experience with product development, design controls, SDLC, and risk management processes.Excellent communication skills, strong documentation practices (protocols and reports), attention to detail, and proficient project management abilities.Company Overview
The company is focused on developing cutting-edge technology to address atrial fibrillation (AF), aiming to improve treatment outcomes for patients. They are working on a high-resolution, real-time, 3D electroanatomical mapping system designed for use in cardiac electrophysiology procedures. This system uses an ultra-high-resolution catheter to generate detailed maps of AF, providing new insights into the condition and enhancing precision during treatment. Their mission is to enable a cure for the millions of individuals affected by AF.Key Opportunities
Leadership in Quality Engineering : The candidate will play a pivotal role in guiding quality initiatives across the entire product lifecycle, from design to commercialization.Collaboration with Cross-Functional Teams : Working closely with teams across software, hardware, data science, and operations, the candidate will support diverse engineering and quality efforts.Impact on Cutting-Edge Medical Devices : The opportunity to contribute to the development of advanced medical technologies, improving patient outcomes.Regulatory and Compliance Expertise : Involvement in maintaining and enhancing compliance with key regulatory standards like ISO 13485, 21 CFR 820, and IEC 62304, furthering the candidate's expertise in the medical device industry.Continuous Professional Growth : The role offers the chance to stay updated on evolving external standards, expand risk management skills, and manage quality systems to scale products for commercialization.Mentorship and Leadership Opportunities : The candidate will train and mentor QA team members, as well as support internal audits and compliance, contributing to team development and broader organizational success.
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Act as the representative during all phases of product development, including design, verification, validation, transfer, and design reviews.Participate in risk management activities, ensuring comprehensive analysis and documentation throughout the product development lifecycle.Provide support to design teams for software, hardware, and data science during the design control process and Software Development Life Cycle (SDLC).Support sustaining engineering efforts through activities like material control, process improvement, inspections, nonconforming material management, equipment qualification, and supplier oversight.Perform inspections and testing of materials, equipment, processes, and products to ensure compliance with quality specifications.Develop and implement quality system processes to meet regulatory requirements.Conduct cross-functional training on quality and compliance best practices and mentor members of the QA team.Assist in internal audit processes and ensure readiness for external ISO 13485 certification.Stay updated on external standards to enhance compliance efforts in preparation for product commercialization.Minimum Requirements
Bachelor's degree in mechanical, biomedical, or a related engineering discipline.Minimum of 8 years of experience in quality engineering or a similar position within a regulated industry.Background in software, data science, hardware/systems design, or medical device development within a Quality Management System.Strong understanding of regulations such as 21 CFR 820, ISO 13485:2016, and IEC 62304:2006.Hands-on experience with product development, design controls, SDLC, and risk management processes.Excellent communication skills, strong documentation practices (protocols and reports), attention to detail, and proficient project management abilities.Company Overview
The company is focused on developing cutting-edge technology to address atrial fibrillation (AF), aiming to improve treatment outcomes for patients. They are working on a high-resolution, real-time, 3D electroanatomical mapping system designed for use in cardiac electrophysiology procedures. This system uses an ultra-high-resolution catheter to generate detailed maps of AF, providing new insights into the condition and enhancing precision during treatment. Their mission is to enable a cure for the millions of individuals affected by AF.Key Opportunities
Leadership in Quality Engineering : The candidate will play a pivotal role in guiding quality initiatives across the entire product lifecycle, from design to commercialization.Collaboration with Cross-Functional Teams : Working closely with teams across software, hardware, data science, and operations, the candidate will support diverse engineering and quality efforts.Impact on Cutting-Edge Medical Devices : The opportunity to contribute to the development of advanced medical technologies, improving patient outcomes.Regulatory and Compliance Expertise : Involvement in maintaining and enhancing compliance with key regulatory standards like ISO 13485, 21 CFR 820, and IEC 62304, furthering the candidate's expertise in the medical device industry.Continuous Professional Growth : The role offers the chance to stay updated on evolving external standards, expand risk management skills, and manage quality systems to scale products for commercialization.Mentorship and Leadership Opportunities : The candidate will train and mentor QA team members, as well as support internal audits and compliance, contributing to team development and broader organizational success.
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