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 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 Referrals increase your chances of interviewing at EnIn Systems by 2x Sign in to set job alerts for “Validation Engineer” roles. Elkton, MD $86,000.00-$129,000.00 3 weeks ago Rockville, MD $85,500.00-$111,250.00 6 days ago Annapolis Junction, MD $12,000.00-$180,000.00 1 month ago Lead Validation Engineer or Specialist, Equipment Silver Spring, MD $122,000.00-$150,000.00 3 days ago Columbia, MD $130,000.00-$180,000.00 1 month ago Customer Quality Engineer (CQE) (Onsite) Hanover, MD $70,000.00-$150,000.00 1 day ago Walkersville, MD $100,000.00-$170,000.00 4 days ago Fort Meade, MD $107,000.00-$113,000.00 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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