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Principal Validation Engineer - Medical Device #4150
Accepting applicationsECI · Bedford, MA
Full-Time Principal aiarmatementorrf
Posted
6d ago
Category
Test
Experience
Principal
Country
United States
Brief Description
About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role
We are seeking an experienced Principal Validation Engineer with 10+ years' experience to lead validation strategy and execution for medical device products, manufacturing processes, equipment, facilities, and computerized systems. This role provides technical leadership across cross-functional teams and ensures compliance with FDA, ISO 13485, EU MDR, and global regulatory requirements. The ideal candidate combines deep validation expertise with strong project leadership and mentoring capabilities.
What You'll Do
Develop and execute validation protocols and reports.
Validate manufacturing equipment, processes, software systems, and test methods
Support process validation for new product introductions and process changes
Perform risk assessments and support CAPA activities
Review engineering changes for validation impact
Collaborate with Quality, Manufacturing, R&D, Regulatory Affairs, and suppliers
Analyze validation data and prepare technical documentation
Participate in audits and inspections
Maintain validation master plans and documentation systems
What We Look For
AVI / Visual Inspection Expertise
Automatic Visual Inspection (AVI) systems validation
Manual Visual Inspection (MVI) program knowledge
Experience with:
Knapp systems strongly preferred
Seidenader, Antares, Eisai, or similar acceptable
Two-stage inspection strategies (AVI + MVI)
Validation Experience
IQ/OQ/PQ execution and review
PPQ interpretation and support
Seeded defect studies
Defect detection rate analysis
AQL sampling and acceptance criteria
Pharma / Inspection Science
Sterile injectable or parenteral manufacturing experience
USP and USP familiarity
Visual inspection defect standards and qualification methodology
Regulatory / Risk Assessment
FDA-facing validation documentation experience
Prior Approval Supplement (PAS) support preferred
Ability to assess regulatory impact/risk of validation findings
Experience supporting audits, inspections, or regulatory submissions
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI another 3rd party vendor.
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About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role
We are seeking an experienced Principal Validation Engineer with 10+ years' experience to lead validation strategy and execution for medical device products, manufacturing processes, equipment, facilities, and computerized systems. This role provides technical leadership across cross-functional teams and ensures compliance with FDA, ISO 13485, EU MDR, and global regulatory requirements. The ideal candidate combines deep validation expertise with strong project leadership and mentoring capabilities.
What You'll Do
Develop and execute validation protocols and reports.
Validate manufacturing equipment, processes, software systems, and test methods
Support process validation for new product introductions and process changes
Perform risk assessments and support CAPA activities
Review engineering changes for validation impact
Collaborate with Quality, Manufacturing, R&D, Regulatory Affairs, and suppliers
Analyze validation data and prepare technical documentation
Participate in audits and inspections
Maintain validation master plans and documentation systems
What We Look For
AVI / Visual Inspection Expertise
Automatic Visual Inspection (AVI) systems validation
Manual Visual Inspection (MVI) program knowledge
Experience with:
Knapp systems strongly preferred
Seidenader, Antares, Eisai, or similar acceptable
Two-stage inspection strategies (AVI + MVI)
Validation Experience
IQ/OQ/PQ execution and review
PPQ interpretation and support
Seeded defect studies
Defect detection rate analysis
AQL sampling and acceptance criteria
Pharma / Inspection Science
Sterile injectable or parenteral manufacturing experience
USP and USP familiarity
Visual inspection defect standards and qualification methodology
Regulatory / Risk Assessment
FDA-facing validation documentation experience
Prior Approval Supplement (PAS) support preferred
Ability to assess regulatory impact/risk of validation findings
Experience supporting audits, inspections, or regulatory submissions
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI another 3rd party vendor.
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