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VnV Lead
Job Location:
Job Location:
Andover, KS - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
19 June 2026 (30+ days ago)
Posted:
Application Deadline:
16 September 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Job Title: VnV Lead
Location: Andover 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:
Job Description:
About the Role
We are seeking a Verification Lead to own the verification strategy for our medical device products and ensure that our software and systems meet their specified requirements and in compliance with applicable regulatory standards (FDA and notified body audits).
This is a hands-on technical leadership role that bridges engineering quality and regulatory affairs.
You will design verification protocols drive risk-based test coverage and mentor a team of verification engineers.
This is a hands-on technical leadership role that bridges engineering quality and regulatory affairs.
You will design verification protocols drive risk-based test coverage and mentor a team of verification engineers.
Key Responsibilities
Verification Strategy & Planning
- Author and maintain the Verification Plan (and associated Master V&V Plan) covering software system and subsystem verification activities.
- Define the verification approach in alignment with the IEC 62304 software development lifecycle scaled to the products software safety classification (Class A/B/C).
- Establish verification scope methods acceptance criteria entry/exit criteria and resource and schedule estimates.
- Define and maintain requirements-to-test traceability ensuring every requirement and risk control measure is verified.
Risk-Based Verification
- Integrate verification with the risk management process per ISO 14971 ensuring that risk control measures are verified for effectiveness and that residual risk acceptability is supported by objective evidence.
- Prioritize and scale test coverage according to risk software safety class and hazard analysis outputs.
- Verify that risk controls implemented in software are correctly traced tested and documented.
Test Protocol Design & Execution
- Design test protocols and test cases for unit integration software system and overall system verification.
- Specify test environments test data tools fixtures and pass/fail criteria.
- Oversee protocol execution review test records and adjudicate anomalies and deviations.
- Manage the defect/anomaly lifecycle: triage root cause support regression strategy and verification of fixes.
Reviews & Technical Governance
- Lead and facilitate design reviews requirements reviews test protocol reviews and verification results reviews.
- Review verification deliverables for completeness traceability and audit-readiness.
- Serve as a gatekeeper at design milestones providing objective verification evidence for design transfer and release decisions.
Documentation & Compliance
- Produce verification deliverables suitable for the Design History File (DHF) and regulatory submissions.
- Ensure compliance with IEC 62304 ISO 14971 ISO 13485 IEC 62366-1 (usability where applicable) FDA 21 CFR 820 Design Controls and EU MDR.
- Support internal and external audits notified body assessments and regulatory questions related to verification.
Leadership
- Mentor and provide technical direction to verification engineers.
- Coordinate cross-functionally with software development systems engineering quality and regulatory affairs.
- Continuously improve verification methods tooling automation and metrics.
Required Qualifications
- Bachelors degree in engineering computer science or a related technical field (or equivalent experience).
- 8 years in verification V&V in medical devices.
- Demonstrated working knowledge of IEC 62304 (software lifecycle and safety classification) and ISO 14971 (risk management).
- Proficient in connected devices embedded systems or SaMD (Software as a Medical Device).
- Experience authoring verification plans and designing test protocols from requirements.
- Strong grasp of requirements traceability and design control processes.
- Experience leading technical reviews and producing audit-ready documentation.
- Excellent written communication; able to write protocols and reports that withstand regulatory review.
- Experience supporting regulatory submissions and notified body audits.
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.
