Job Requirements

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 10–15 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 ResponsibilitiesQuality 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.

Work Experience
Key Skills and QualificationsEducational 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: 10–15 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 UsedQuality 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.