• Must 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 EMC according to 60601-1

The pay range that the employer in good faith reasonably expects to pay for this position is $24.04/hour - $37.56/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.

Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.