Requirements (Must have)
• Proven 3 – 5 years of experience as an Electrical Engineer in Medical Devices domain, manufacturing electrical, mechanical, or software-based products.
• Knowledge of electronics engineering and related processes, preferably in the Medical Device domain
• Experience in BOM creation, ROHS compliance, Reviewing PCB layout
• Experience in technical documentation involved in design processes like ECR, ECO, MCO
• High speed circuit layout, multiple layers, blind vias, EMI/EMC,IPC A610 and RFI guidelines for PCB.
• Good experience in multiple ECAD packages i.e. PCB designs in OrCAD, CADSTAR, Cadence Allegro, Altium, Mentor Graphics DxDesigner, etc.
• Electronics board troubleshooting, Prototype building and testing.
• Current Good Manufacturing Practices, and ISO 13485 Quality Management Systems for Medical Devices
• Familiarity with medical device risk management (ISO 14971)
• Familiarity with medical device safety standards (IEC 60601)
• Proficiency in Analog and Digital design, simulation and Analysis.
• Experience with auditing and reporting procedures
Requirements (Good to have)
• Experience of working on Agile projects
• Experience of working with distributed agile teams in offshore/onsite model
Soft skills (Must have)
• Excellent communication and presentation skills
• Positive attitude towards learning/challenges/team/etc.
Essential Duties & Responsibilities
• Analysing and extracting system requirements and generating a System Requirements Specifications.
• Support Electronics Architecture Design in agreement with System Requirements
• Strong cooperation with hardware and software engineers
• Prepare documentation with the end goal of system qualification and product certification.
• Support creation of Software and Hardware Requirements Specifications incl. traceability to System Requirements
• Design electronic systems, products, software and components for medical applications.
• Create testing procedures and maintenance for electronic equipment and components.
• Recommend design modifications and equipment repair.
• Inspect electronic systems, instruments and equipment to ensure they meet applicable regulations and safety standards.
• Support System Test Specifications and traceability to requirements
• Comply to process requirements and meet standards .
• Understanding and implementing designs from technical drawings
• Interacting with contractors and customers using verbal and written communication
• Testing electronics for problems and proposing solutions
• Perform electrical or electronic design maintenance due to component obsolescence or value engineering proposals to include testing and validation as required
• Write and coordinate the implementation of engineering change orders
• Drive continuous improvement on released hardware products
• Identify potential medical device hazards and maintains Risk Management files
• Support the service depot for product design quality issues and the maintenance of service parts kits as defined by Customer Service Department
• Deliver medical device design documentation compliant with FDA design controls and good documentation practices
• Conduct medical device safety testing and maintains product compliance with applicable UL, ISO, and IEC 60601 standards as well as international regulatory requirements
• Investigate and resolve corrective and preventative actions using appropriate problem solving techniques (DMAIC, FMEA, Ishikawa, etc