AMT Consulting, LLC
Overview
Sr. Systems Engineer – Medical Device Development at AMT Consulting | Medical Device Design & Development. Location: Hybrid / Remote – Occasional travel to client sites (≤10%). This role focuses on bringing medical devices from concept through commercialization, collaborating across clinical, business, and engineering teams to define, integrate, and validate complex medical systems in compliance with global regulatory standards. Responsibilities
Serve as a liaison between clinical/marketing, program management, and engineering design teams. Translate clinical and business needs into system-level requirements for engineering definition and design. Develop and consult on test method adequacy and verification strategy for device requirements. Build prototypes, test fixtures, and software tools for data acquisition, evaluation, and analysis. Collaborate across software, hardware, firmware, and mechanical teams to provide hands-on troubleshooting and integration support. Apply sound engineering principles and documentation practices to conduct design reviews, failure analyses, and risk evaluations. Lead the design, implementation, and integration of system features and subsystems to deliver safe, effective, and high-performing medical technologies. Take ownership of assigned features or components, from hazard/risk analysis and requirements definition through verification and validation. Drive system integration across software, hardware, and mechanical subsystems to ensure seamless functionality and performance. Participate in usability assessments, formative evaluations, and design testing to validate system behavior and user interaction. Operate independently on complex projects, providing technical leadership and documentation excellence throughout the product lifecycle. Take on additional responsibilities as needed to support client needs and ensure project success. Required Skills & Capabilities
Requirements Management
Develop user needs, system requirements, and subsystem requirements for hardware and software, including acceptance criteria. Decompose and allocate requirements across cross-functional disciplines. Identify and manage dependencies between hardware, software, and mechanical subsystems. Product Development & System Design
Design system behavior and user interaction within the intended clinical environment. Strong understanding of design control processes and lifecycle phases in FDA-regulated product development. Develop system-level architecture diagrams and interface definitions. Apply expertise in hardware and software integration for complex systems. Conduct risk analyses and maintain risk registries (Hazard Analysis, aFMEA, etc.) for multi-component devices. Strong analytical and problem-solving skills to decompose complex engineering challenges into actionable elements. Working knowledge of CAD tools, prototype design, and transformation math. Proficiency in MATLAB, Python, C#, C++, or similar languages for prototyping, data acquisition, and data analysis. Understanding of statistics and DOE methods (t-test, ANOVA) using tools such as Minitab or R. Project Management
Experience working within Agile or hybrid development environments. Ability to manage deliverables, track dependencies, and communicate risks and priorities effectively. Additional Qualities
Strong communication and influence skills across multidisciplinary teams. Ability to collaborate with engineers, clinicians, and leadership to balance technical and business objectives. Demonstrated self-awareness, accountability, and proactive problem-solving. Skilled at conveying technical content clearly to both technical and non-technical audiences. Qualifications / Education
Bachelor’s degree in Mechanical, Biomedical, Electrical, or Systems Engineering (or equivalent). 5–7 years of experience in complex medical device product development within an FDA-regulated environment. Experience working under FDA design controls (21 CFR 820) and relevant standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366). Experience in surgical, diagnostic, or therapeutic system development preferred. Startup or early-stage development experience preferred, with demonstrated ability to operate in dynamic, fast-paced environments.
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Sr. Systems Engineer – Medical Device Development at AMT Consulting | Medical Device Design & Development. Location: Hybrid / Remote – Occasional travel to client sites (≤10%). This role focuses on bringing medical devices from concept through commercialization, collaborating across clinical, business, and engineering teams to define, integrate, and validate complex medical systems in compliance with global regulatory standards. Responsibilities
Serve as a liaison between clinical/marketing, program management, and engineering design teams. Translate clinical and business needs into system-level requirements for engineering definition and design. Develop and consult on test method adequacy and verification strategy for device requirements. Build prototypes, test fixtures, and software tools for data acquisition, evaluation, and analysis. Collaborate across software, hardware, firmware, and mechanical teams to provide hands-on troubleshooting and integration support. Apply sound engineering principles and documentation practices to conduct design reviews, failure analyses, and risk evaluations. Lead the design, implementation, and integration of system features and subsystems to deliver safe, effective, and high-performing medical technologies. Take ownership of assigned features or components, from hazard/risk analysis and requirements definition through verification and validation. Drive system integration across software, hardware, and mechanical subsystems to ensure seamless functionality and performance. Participate in usability assessments, formative evaluations, and design testing to validate system behavior and user interaction. Operate independently on complex projects, providing technical leadership and documentation excellence throughout the product lifecycle. Take on additional responsibilities as needed to support client needs and ensure project success. Required Skills & Capabilities
Requirements Management
Develop user needs, system requirements, and subsystem requirements for hardware and software, including acceptance criteria. Decompose and allocate requirements across cross-functional disciplines. Identify and manage dependencies between hardware, software, and mechanical subsystems. Product Development & System Design
Design system behavior and user interaction within the intended clinical environment. Strong understanding of design control processes and lifecycle phases in FDA-regulated product development. Develop system-level architecture diagrams and interface definitions. Apply expertise in hardware and software integration for complex systems. Conduct risk analyses and maintain risk registries (Hazard Analysis, aFMEA, etc.) for multi-component devices. Strong analytical and problem-solving skills to decompose complex engineering challenges into actionable elements. Working knowledge of CAD tools, prototype design, and transformation math. Proficiency in MATLAB, Python, C#, C++, or similar languages for prototyping, data acquisition, and data analysis. Understanding of statistics and DOE methods (t-test, ANOVA) using tools such as Minitab or R. Project Management
Experience working within Agile or hybrid development environments. Ability to manage deliverables, track dependencies, and communicate risks and priorities effectively. Additional Qualities
Strong communication and influence skills across multidisciplinary teams. Ability to collaborate with engineers, clinicians, and leadership to balance technical and business objectives. Demonstrated self-awareness, accountability, and proactive problem-solving. Skilled at conveying technical content clearly to both technical and non-technical audiences. Qualifications / Education
Bachelor’s degree in Mechanical, Biomedical, Electrical, or Systems Engineering (or equivalent). 5–7 years of experience in complex medical device product development within an FDA-regulated environment. Experience working under FDA design controls (21 CFR 820) and relevant standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366). Experience in surgical, diagnostic, or therapeutic system development preferred. Startup or early-stage development experience preferred, with demonstrated ability to operate in dynamic, fast-paced environments.
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