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Validation Engineer – Medical Device

EnIn Systems

Maryland

On-site

USD 86,000 - 129,000

Full time

30+ days ago

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Job summary

A leading company in software development seeks an Embedded S/W Engineer for validation activities in a medical device environment. Candidates should have a bachelor's degree in engineering and at least 3 years of validation experience in the medical device industry, with knowledge of FDA and ISO standards. The role involves developing validation protocols and collaborating across teams to ensure compliance and quality throughout the validation lifecycle. This full-time position offers competitive salary and growth opportunities in the field of regulatory compliance.

Qualifications

3+ years of hands-on validation experience in the medical device industry.
Strong knowledge of GMP, FDA 21 CFR 820, and ISO 13485.
Experience developing and executing validation protocols.

Responsibilities

Develop IQ/OQ/PQ protocols for medical device validation.
Conduct design verification and validation testing.
Collaborate with R&D and QA teams.

Skills

Analytical skills

Problem-solving skills

Good communication

Cross-functional team collaboration

Education

Bachelor's degree in Biomedical, Mechanical, Electrical, or related Engineering discipline

Tools

TrackWise

MasterControl

Veeva Vault

1 week ago Be among the first 25 applicants

Direct message the job poster from EnIn Systems

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