Validation Engineer – Medical Device

EnIn Systems · United States

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Actively Hiring Embedded S/W engineer ( Only on W2) ( All thevisa's are Recommended)

Key Responsibilities:

• Develop and execute IQ/OQ/PQ protocols for equipment, utilities, and manufacturing processes in a medical device environment.
• Plan and perform process validation, test method validation, and software validation (CSV) activities.
• Author and review Validation Master Plans (VMP), Risk Assessments, URS, FRS, Traceability Matrices, and Validation Reports .
• Collaborate with R&D, Quality Assurance, Regulatory Affairs, and Production teams to ensure validation deliverables align with product and process requirements.
• Conduct design verification and validation testing (DV&V) for medical devices as part of design control.
• Support regulatory audits and inspections by providing validation documentation and technical expertise.
• Manage and document deviations, CAPAs, and change controls related to validation activities.
• Maintain compliance with FDA QSR, ISO 13485, and GMP guidelines throughout the validation lifecycle.

Required Skills & Qualifications:

• Bachelor’s degree in Biomedical, Mechanical, Electrical, or related Engineering discipline .
• 3+ years of hands-on validation experience in the medical device industry .
• Strong knowledge of GMP, FDA 21 CFR 820, ISO 13485, ISO 14971, and risk-based validation approaches .
• Experience developing and executing equipment, process, cleaning, and computer system validation protocols .
• Excellent documentation, analytical, and problem-solving skills.
• Good communication and cross-functional team collaboration abilities.

Preferred Qualifications:

• Familiarity with electromechanical and embedded medical device validation .
• Experience with software validation under FDA and IEC 62304 guidelines .
• Working knowledge of TrackWise, MasterControl, or Veeva Vault for documentation management.
• Certification in CQE, CQA, or RAC is a plus.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Software Development and IT Services and IT Consulting

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