Validation Engineer – Medical Devices

Engineering Resource Group, Inc.; Denville (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Engineering Resource Group, Inc. is seeking a Validation Engineer for a contract role focused on quality-system remediation at a medical device manufacturer.

The role involves risk assessment, CAPA remediation, hazard analyses, and V&V to address regulatory findings and open quality records. Responsibilities include building remediation plans, drafting CAPA documentation, and coordinating cross-functional sessions with Product Development, Quality, Regulatory, and Manufacturing.

Qualifications

• Minimum 7 years of experience with risk management, CAPA remediation, design controls, and V&V.
• Strong working knowledge of design controls, risk management, requirements and traceability management, and good documentation practices.
• Experience authoring or updating hazard analyses, design and process FMEAs, risk-control measures, and risk-management reports.
• Ability to judge V&V impact of changes and generate technically defensible objective evidence.
• Strong technical writing skills with inspection-ready documentation.

Responsibilities

• Contract position for a Validation Engineer supporting quality-system remediation at a medical device manufacturer.
• Assess product and process risk and drive corrective action tied to regulatory findings and open quality records.
• Perform or refresh hazard analyses and design/process FMEAs to rank product, process, and compliance risk.
• Review regulatory observations, CAPAs, investigations, complaints etc. to locate gaps in root-cause analysis, risk controls, traceability, and objective evidence.
• Build a risk-based remediation plan mapping findings and CAPA commitments to root causes, corrective actions, verification activities, owners, and due dates.
• Draft or revise CAPA records spanning problem definition, containment, investigation strategy, root-cause analysis, corrections, and effectiveness checks.
• Determine when design, process, supplier, or CAPA changes trigger additional verification or validation, and define the test plans, protocols, acceptance criteria, and traceability required.
• Assemble inspection-ready documentation and evidence packages for regulatory review, management review, and audit.
• Facilitate cross-functional sessions across Product Development, Quality, Regulatory, and Manufacturing, report weekly on deliverables and open risks, and deliver a final status report and knowledge-transfer handoff.
• BS Engineering.

Skills

Risk management

CAPA remediation

Design controls

V&V (verification and validation)

Regulatory knowledge

Technical writing

Cross-functional collaboration

Education

BS Engineering

Tools

eQMS

FMEA

Job description

Responsibilities & Qualifications

• Contract position for a Validation Engineer supporting quality-system remediation at a medical device manufacturer.
• Assess product and process risk and drive corrective action tied to regulatory findings and open quality records.
• Perform or refresh hazard analyses and design/process FMEAs to rank product, process, and compliance risk.
• Review regulatory observations, CAPAs, investigations, complaints etc. to locate gaps in root-cause analysis, risk controls, traceability, and objective evidence.
• Build a risk-based remediation plan mapping findings and CAPA commitments to root causes, corrective actions, verification activities, owners, and due dates.
• Draft or revise CAPA records spanning problem definition, containment, investigation strategy, root-cause analysis, corrections, and effectiveness checks.
• Determine when design, process, supplier, or CAPA changes trigger additional verification or validation, and define the test plans, protocols, acceptance criteria, and traceability required.
• Assemble inspection-ready documentation and evidence packages for regulatory review, management review, and audit.
• Facilitate cross-functional sessions across Product Development, Quality, Regulatory, and Manufacturing, report weekly on deliverables and open risks, and deliver a final status report and knowledge-transfer handoff.
• BS Engineering.
• Minimum 7 years of experience with risk management, CAPA remediation, design controls, and verification and validation (V&V) Working knowledge of design controls, risk management, requirements and traceability management, and good documentation practices.
• Experience authoring or updating hazard analyses, design and process FMEAs, risk-control measures, and risk-management reports.
• Experience judging the V&V impact of design, process, supplier, or CAPA changes and generating technically defensible objective evidence.
• Strong technical writing skills with a track record of clear, inspection-ready documentation.
• Ability to work independently, manage competing priorities, and challenge assumptions constructively.
• Experience with document-control, CAPA, requirements-management, or electronic quality (eQMS) systems a plus.