System Verification Engineer Lead
Job Location:
Waltham, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Job Title: System Verification Engineer - Lead
Location: Waltham MA
Position Type: Contract
Duration: 6 / 12 Month
Work Type: Onsite
Rate: Pay range offered to a successful candidate will be based on several factors including the candidates education work experience work location specific job duties certifications etc.Job 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.
- Leads and assists with industry-based standards testing for safety and EMC according to 60601-1
ABOUT Ztek:
Ztek Consulting Inc is a minority- and woman-owned business enterprise that leverages a unique blend of human talent machine learning algorithms and artificial intelligence to provide customized talent management solutions for clients. Zteks diversity-focused hiring models have proven successful particularly in hiring veterans. The companys veteran-focused hiring and deployment program Z-V.E.T matches skilled veterans with clients needs in various areas.
Disclaimer:
Ztek is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Ztek is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race color religion or belief national origin citizenship social or ethnic origin sex age physical or mental disability veteran status marital status domestic partner status sexual orientation or any other status protected by the statutes rules and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment please contact us at Please indicate the specifics of the assistance needed. Ztek encourages all interested and qualified candidates to apply for employment opportunities. Ztek does not discriminate against applicants based on citizenship status immigration status or national origin in accordance with 8 U.S.C. 1324b.
