System Verification Engineer - Lead

Role:
System Verification Engineer - Lead

Work location:

Waltham, MA (On Site)
Years of Experience required: 3 - 4 years.
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.
Leads and assists with industry-based standards testing for safety and EClient according to 60601-1