ECAD Engineer

We are seeking an experienced ECAD Engineer with strong expertise in PWB/PCB layout design and Mentor/Siemens Xpedition. The ideal candidate should have experience in analog, digital, and mixed-signal PCB layouts, along with schematic entry and fabrication package generation.

• 8-12 years of experience in PWB/PCB layout design.
• Expertise in Mentor/Siemens Xpedition tools.
• Experience in Analog, Digital, and Mixed-Signal Layout Design.
• Strong experience with Schematic Entry and PCB Layout Design.
• Experience generating PCB fabrication packages.
• Experience working with complete PCB design and layout processes.
• Cadence design experience is an added advantage.
• Ability to work independently in a remote environment.

Required Skills:

• ECAD / PCB Layout Design
• Mentor/Siemens Xpedition
• PWB/PCB Layout
• Analog, Digital & Mixed-Signal Design
• Schematic Entry
• Fabrication Package Generation
• Cadence - preferred
• Lead Design Quality Engineering (DQE) activities throughout the product development lifecycle.
• Provide Quality Engineering support for new product development, design changes, and product improvements.
• Review and approve design inputs, outputs, verification, validation, and design documentation.
• Support and maintain Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) documentation.
• Lead or support risk management activities, including ISO 14971 risk analysis, FMEA, and risk controls.
• Develop and execute design verification and validation (DV&V) strategies and ensure appropriate objective evidence.
• Partner with Engineering to identify and resolve design-related quality issues and nonconformances.
• Lead root cause analysis, CAPA, deviations, and corrective/preventive actions related to product and design quality.
• Ensure compliance with 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and applicable medical-device requirements.
• Participate in design reviews, phase-gate reviews, and technical risk assessments.
• Evaluate and approve engineering changes, supplier changes, and product/process modifications from a quality perspective.
• Support supplier and contract manufacturer quality activities related to product design and development.
• Prepare for and support internal, external, and regulatory audits and inspections.
• Establish and monitor quality metrics, product quality trends, and risk indicators.
• Collaborate with R&D, Regulatory Affairs, Manufacturing, Clinical, Reliability, and Supplier Quality teams.
• Mentor junior Quality Engineers and provide guidance on design controls and quality-system requirements.