Description

• Mus have Hands-on experience in remediation programs, including gap analysis, DHF remediation, design remediation, and compliance remediation
• Ability to identify gaps in processes, documentation, and design, and implement corrective actions aligned with QMS, FDA, and ISO standards
• Experience in maintaining design traceability (requirements, verification, and validation artifacts) and ensuring documentation completeness
• Proven capability to support audit readiness and drive closure of compliance findings
• Effective collaboration with cross-functional teams to execute remediation plans and sustain quality improvements.
• Good understanding of product development life cycle especially in electro-mechanical medical device
• Experience of working in medical device is mandatory – at least 2 full cycle system verification of products (e.g. 3-4 years of working experience in medical device out of total 8 – 12 years of working experience)
• Defines and analyzes system requirements, clinical workflows, and input/output processes by using current systems engineering methods and technologies.
• Experience of system verification (working in Lab) of electro-mechanical products, mixed Hardware & software systems – at least one full cycle starting from understanding of product requirement till system verification
• Hands on experience in test method validation, especially analysis based on intended usage collecting objective evidence on consistent basis.
• Knowledge of risk management of product – failure mode analysis and articulating system verification test cases
• Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables. Creating test set-up including experience in handling of test fixture especially on trouble shooting, making it work, collecting consistent data.
• Good knowledge about lab equipment like DSO (digital storage oscilloscope), multimeter, logic analyzer etc.
• Knowledge of Analog and digital electronic design like DC-DC power supply, sensors interfaces, microcontrollers etc.
• Execution of tests, including user level experience in working with Linux workstation 
• Report writing, discussion with various stakeholders including product requirements, QA & RA teams
• Knowledge in OOO programming languages such as Python, JAVA, C++ is an added advantage.
• Expertise in communication protocols like CAN, RS485, RS232, Ethernet, USB, I2C, SPI, UART
• Good communication – oral & writing ability.
• Great team leadership ability – technical reviewing & technical mentoring
• Provides technical leadership on a cross-functional engineering team.
• Documents system architecture and design control elements by writing documents, reports, and memos.
• Translates customer needs into technical requirements, engaging the field, marketing, service and other functions as needed

Key Skills

Education

Bachelor's degree