EnIn Systems
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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 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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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.
#J-18808-Ljbffr