Quest Global
Principal Design Quality Engineer
The Principal Design Quality Engineer will play a pivotal role in ensuring the quality, safety, and reliability of neurovascular and neuromodulation systems as part of our New Product Development (NPD) efforts, with a focus on advanced deep brain stimulation (DBS) systems like the Percept RC Neurostimulator. The ideal candidate will bring 1015 years of experience in Design Quality within the MedTech industry, with a strong background in electrical and electromechanical systems engineering and system-level expertise in neurovascular applications. Roles and Responsibilities
Quality Assurance Leadership : Oversee the implementation of quality assurance processes throughout the design and development lifecycle of neurostimulation devices, ensuring compliance with regulatory standards and industry best practices. Design Control and Verification : Lead design control activities, including the development and execution of design verification and validation plans, to ensure that neurovascular and neuromodulation systems meet performance, safety, and reliability requirements. Risk Management : Conduct risk assessments (e.g., FMEA, Hazard Analysis) for electrical and electromechanical systems to identify potential failure modes and implement mitigation strategies in accordance with ISO 14971. System-Level Integration : Provide system-level quality oversight for the integration of hardware, software, and firmware components in DBS systems, ensuring seamless functionality and compatibility with advanced features like sensing and closed-loop therapy. Regulatory Compliance : Ensure all design and development activities comply with FDA regulations, ISO 13485, IEC 60601, and other relevant medical device standards, preparing documentation for regulatory submissions. Testing and Validation : Develop and oversee test protocols for electrical and electromechanical systems, including bioelectric signal processing components, to validate performance under various conditions, including MRI compatibility (1.5T and 3T). Cross-Functional Collaboration : Work closely with R&D, engineering, clinical, and manufacturing teams to align quality objectives with product development goals, providing technical guidance on system-level design challenges. Documentation and Traceability : Maintain comprehensive documentation, including Design History Files (DHF), Device Master Records (DMR), and quality plans, to ensure traceability and audit readiness. Continuous Improvement : Drive continuous improvement initiatives by analyzing quality data, identifying trends, and implementing corrective and preventive actions (CAPA) to enhance product reliability and performance. Supplier Quality : Collaborate with suppliers to ensure components for neurostimulation systems meet quality standards, particularly for electrical and electromechanical parts critical to device functionality. Key Skills and Qualifications Educational Background : Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, or a related field. Advanced certifications in quality engineering (e.g., CQE) are preferred. Experience : 1015 years of experience in Design Quality within the MedTech industry, with a focus on supporting neurovascular NPD programs. Experience with DBS or similar neuromodulation systems is highly desirable. Technical Expertise :
Strong background in electrical and electromechanical systems engineering, including design and testing of implantable medical devices. System-level experience with neurostimulation systems, including familiarity with bioelectric signal processing (e.g., local field potentials or LFPs). Proficiency in risk management methodologies (e.g., FMEA, ISO 14971) and design control processes.
Regulatory Knowledge : In-depth understanding of medical device regulations, including FDA 21 CFR Part 820, ISO 13485, IEC 60601, and other relevant standards. Analytical Skills : Ability to analyze complex system-level data, including electrical performance metrics and failure modes, to drive quality improvements. Problem-Solving : Proven ability to identify, troubleshoot, and resolve quality-related issues in the design and development of medical devices. Communication and Leadership : Excellent communication skills to collaborate with cross-functional teams and provide leadership in quality assurance activities. Attention to Detail : Strong focus on detail to ensure compliance with stringent quality and regulatory requirements. Software and Tools Used
Quality Management Systems : Software for managing quality processes, such as MasterControl, Greenlight Guru, or similar platforms. Risk Management Tools : Tools like ReliaSoft or Minitab for conducting Failure Modes and Effects Analysis (FMEA) and other risk assessments. Design and Simulation Software : MATLAB, LabVIEW, or PSpice for analyzing electrical and electromechanical system performance. Documentation Tools : DOORS, Jama Connect, or similar platforms for managing design control documentation and traceability. Data Analysis : Python (e.g., NumPy, Pandas) or R for analyzing quality data and identifying trends. CAD and Schematic Tools : Altium Designer or OrCAD for reviewing electrical schematics and PCB layouts. Regulatory Compliance Tools : Software for preparing and managing regulatory submissions, such as electronic Common Technical Document (eCTD) tools. Testing and Validation Tools : Custom scripts or software for validating bioelectric signal processing and system performance, including tools for MRI compatibility testing.
The Principal Design Quality Engineer will play a pivotal role in ensuring the quality, safety, and reliability of neurovascular and neuromodulation systems as part of our New Product Development (NPD) efforts, with a focus on advanced deep brain stimulation (DBS) systems like the Percept RC Neurostimulator. The ideal candidate will bring 1015 years of experience in Design Quality within the MedTech industry, with a strong background in electrical and electromechanical systems engineering and system-level expertise in neurovascular applications. Roles and Responsibilities
Quality Assurance Leadership : Oversee the implementation of quality assurance processes throughout the design and development lifecycle of neurostimulation devices, ensuring compliance with regulatory standards and industry best practices. Design Control and Verification : Lead design control activities, including the development and execution of design verification and validation plans, to ensure that neurovascular and neuromodulation systems meet performance, safety, and reliability requirements. Risk Management : Conduct risk assessments (e.g., FMEA, Hazard Analysis) for electrical and electromechanical systems to identify potential failure modes and implement mitigation strategies in accordance with ISO 14971. System-Level Integration : Provide system-level quality oversight for the integration of hardware, software, and firmware components in DBS systems, ensuring seamless functionality and compatibility with advanced features like sensing and closed-loop therapy. Regulatory Compliance : Ensure all design and development activities comply with FDA regulations, ISO 13485, IEC 60601, and other relevant medical device standards, preparing documentation for regulatory submissions. Testing and Validation : Develop and oversee test protocols for electrical and electromechanical systems, including bioelectric signal processing components, to validate performance under various conditions, including MRI compatibility (1.5T and 3T). Cross-Functional Collaboration : Work closely with R&D, engineering, clinical, and manufacturing teams to align quality objectives with product development goals, providing technical guidance on system-level design challenges. Documentation and Traceability : Maintain comprehensive documentation, including Design History Files (DHF), Device Master Records (DMR), and quality plans, to ensure traceability and audit readiness. Continuous Improvement : Drive continuous improvement initiatives by analyzing quality data, identifying trends, and implementing corrective and preventive actions (CAPA) to enhance product reliability and performance. Supplier Quality : Collaborate with suppliers to ensure components for neurostimulation systems meet quality standards, particularly for electrical and electromechanical parts critical to device functionality. Key Skills and Qualifications Educational Background : Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, or a related field. Advanced certifications in quality engineering (e.g., CQE) are preferred. Experience : 1015 years of experience in Design Quality within the MedTech industry, with a focus on supporting neurovascular NPD programs. Experience with DBS or similar neuromodulation systems is highly desirable. Technical Expertise :
Strong background in electrical and electromechanical systems engineering, including design and testing of implantable medical devices. System-level experience with neurostimulation systems, including familiarity with bioelectric signal processing (e.g., local field potentials or LFPs). Proficiency in risk management methodologies (e.g., FMEA, ISO 14971) and design control processes.
Regulatory Knowledge : In-depth understanding of medical device regulations, including FDA 21 CFR Part 820, ISO 13485, IEC 60601, and other relevant standards. Analytical Skills : Ability to analyze complex system-level data, including electrical performance metrics and failure modes, to drive quality improvements. Problem-Solving : Proven ability to identify, troubleshoot, and resolve quality-related issues in the design and development of medical devices. Communication and Leadership : Excellent communication skills to collaborate with cross-functional teams and provide leadership in quality assurance activities. Attention to Detail : Strong focus on detail to ensure compliance with stringent quality and regulatory requirements. Software and Tools Used
Quality Management Systems : Software for managing quality processes, such as MasterControl, Greenlight Guru, or similar platforms. Risk Management Tools : Tools like ReliaSoft or Minitab for conducting Failure Modes and Effects Analysis (FMEA) and other risk assessments. Design and Simulation Software : MATLAB, LabVIEW, or PSpice for analyzing electrical and electromechanical system performance. Documentation Tools : DOORS, Jama Connect, or similar platforms for managing design control documentation and traceability. Data Analysis : Python (e.g., NumPy, Pandas) or R for analyzing quality data and identifying trends. CAD and Schematic Tools : Altium Designer or OrCAD for reviewing electrical schematics and PCB layouts. Regulatory Compliance Tools : Software for preparing and managing regulatory submissions, such as electronic Common Technical Document (eCTD) tools. Testing and Validation Tools : Custom scripts or software for validating bioelectric signal processing and system performance, including tools for MRI compatibility testing.