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.