Senior Verification & Validation Engineer

Warwick Consulting; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Warwick Consulting Limited is seeking a Senior Verification & Validation Engineer to lead design verification and validation efforts for medical devices. The role emphasizes robust verification strategy, evidence review, and remediation of documentation to ensure device safety and user needs are met.

The ideal candidate will partner with Engineering, R&D, Quality, Regulatory Affairs, and others to ensure traceability, proper design outputs, and regulatory compliance across the product lifecycle.

Qualifications

• Experience with verification strategies, test protocols, and documentation in a regulated medical device environment.
• Ability to assess evidence quality, traceability, and acceptance criteria.
• Strong written and verbal communication across cross-functional teams.

Responsibilities

• Support verification strategy development, plans, and matrices aligned with system requirements.
• Review test evidence, protocols, and reports for completeness, accuracy, and traceability.
• Coordinate with Systems Engineering, R&D, Quality, and Regulatory Affairs to close gaps.
• Lead remediation of DHF records and ensure inspection-ready documentation.

Skills

Verification & Validation

Design controls

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Biomedical Engineering

Job description

Warwick Consulting is a comprehensive medical device and life sciences consulting firm that simplifies complexity across the full product lifecycle, from concept and design through regulatory approval, commercialization, and post-market support. We partner with organizations ranging from early-stage innovators to global industry leaders, delivering tailored, results-driven solutions across engineering, quality systems, regulatory affairs, cybersecurity, risk management, human factors engineering, product quality, and FDA remediation. By integrating deep industry expertise with innovative, AI-enabled solutions, including our VERA QMS Assurance platform, we help clients address complex challenges, strengthen compliance, improve operational efficiency, and accelerate innovation. Our experienced consultants provide flexible on-site, hybrid, and remote support, delivering the right expertise when and where it is needed most.

Position Overview

The Senior Verification & Validation Engineer will support medical device design verification and validation activities, with a focus on verification strategy, review of test evidence, design validation, and remediation of protocols and reports. This role will help ensure that verification and validation documentation provides clear, objective, and traceable evidence that design requirements are met and that the finished device meets user needs and intended uses.

The ideal candidate has a strong Design Controls background and can partner with Engineering, R&D, Quality, Regulatory Affairs and other stakeholders to ensure system requirements are complete, consistent, verifiable, and appropriately linked to design outputs & verification evidence. Experience with Diagnostic Imaging systems is preferred.

This is a hybrid role requiring effective cross-functional collaboration and support for design documentation and product development milestones.

Key Responsibilities

Verification Strategy and Planning

• Support development and review of risk-based verification strategies, plans, and matrices aligned with design inputs, system requirements, risk controls, and applicable design control procedures.
• Confirm that requirements are objectively verifiable and that planned methods, sample sizes, acceptance criteria, and test conditions are appropriate and justified.
• Identify verification coverage gaps, dependencies, test sequencing issues, and evidence needs; coordinate resolution with engineering and project stakeholders.
• Ensure verification activities are appropriately linked to requirements and tracked through completion.

Test Evidence Review and Assessment

• Review test protocols, methods, raw data, results, deviations, and reports for completeness, accuracy, consistency, traceability, and technical adequacy.
• Assess whether test evidence supports stated acceptance criteria and provides objective evidence that applicable design inputs and requirements have been met.
• Identify missing, inconsistent, ambiguous, or insufficient evidence and document remediation actions.
• Evaluate deviations, anomalies, failures, and unexpected results in collaboration with technical teams; support appropriate investigation, impact assessment, and resolution.
• Ensure test documentation clearly identifies the tested configuration, equipment, methods, acceptance criteria, results, and conclusions, as applicable.

Design Validation and Intended Use

• Support design validation planning and documentation to demonstrate that the device meets user needs and intended uses under defined conditions of use.
• Review validation protocols and reports for appropriate user needs, intended-use scenarios, representative users or environments, acceptance criteria, and documented conclusions.
• Coordinate with Systems Engineering, Human Factors, and other relevant teams to align validation evidence with product requirements and intended use, as applicable.
• Identify validation evidence gaps and support development of remediation plans that address the underlying documentation or testing issue.

Protocol and Report Remediation / DHF

• Lead or support remediation of verification and validation protocols, reports, traceability matrices, and related DHF records.
• Assess legacy documentation for gaps in rationale, methods, acceptance criteria, execution records, deviations, conclusions, approvals, and requirement linkage.
• Develop clear, objective, evidence-based remediation actions while preserving the integrity of existing test records and documenting the basis for conclusions.
• Partner with Quality and Regulatory Affairs to ensure remediation is conducted in accordance with approved procedures and applicable requirements.
• Maintain organized, complete, and inspection-ready design verification and validation records.

Cross-Functional Collaboration

• Collaborate with Systems Engineering, R&D, Quality, Regulatory Affairs, and test teams to resolve evidence gaps and drive timely completion.
• Facilitate protocol and report reviews, evidence assessments, remediation planning, and status discussions.
• Communicate technical findings, documentation risks, and project status clearly to stakeholders and leadership.
• Support design reviews, audits, inspection readiness, and broader design documentation remediation initiatives as needed.

Required Qualifications

• Bachelor’s degree in Engineering, Biomedical Engineering, a related technical discipline, or equivalent relevant experience.
• With Minimum 7+ years of experience in medical device verification and validation, test engineering, design assurance, or a related product development function.
• Strong experience developing or reviewing verification strategies, test protocols, test evidence, and technical reports in a regulated medical device environment.
• Experience with design validation and demonstrating that products meet user needs and intended uses.
• Strong DHF and design control background, including review and remediation of design verification and validation documentation.
• Ability to assess evidence quality, requirement coverage, acceptance criteria, deviations, conclusions, and end-to-end traceability.
• Experience identifying documentation and test evidence gaps and driving practical, well-documented remediation actions.
• Strong technical writing, analytical, organizational, and cross-functional communication skills.
• Willingness and ability to travel internationally.
• Experience with Diagnostic Imaging Medical Devices or related imaging systems, preferred.

Work Arrangement

This is a hybrid consulting engagement, requiring a combination of on-site collaboration and remote work based on project needs and client expectations. The individual must be comfortable working independently, engaging directly with client engineering and quality leadership, and taking ownership of assigned remediation activities with minimal day-to-day direction.

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.