Senior Manufacturing Engineer - Medical Device #1548

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

As Senior Manufacturing Engineer you will support the Manufacturing Engineering Team with Manufacturing Process controls remediation activities. This is an onsite role in Taunton, MA.

What You'll Do

•    Execute remediation tasks to address identified validation gaps
•    Update and improve validation documentation to meet current standards
•    Support compliant revalidation and documentation efforts
•    Ensure accurate, complete, and traceable validation records

Gap Assessment Support:

  • Assess PRA (Product Risk Assessment) and pFMEAs to detect validation status and IPM (In Process Controls).
•    Review existing validation documentation (OQ/PQ, test methods, software validation, etc.)
•    Identify discrepancies and documentation deficiencies based on provided checklists or guidance
•    Support risk assessments by gathering data and documenting findings

Remediation Execution:
•    Revise, update and create validation documents, including:     Protocols (OQ/PQ) and Validation reports, work instructions and forms if applicable
•    Execute validation activities such as test runs, data collection, and verification tasks
•    Ensure proper documentation of all testing and results Documentation & Compliance
•    Ensure documentation aligns with: U.S. Food and Drug Administration (FDA) requirements (e.g., 21 CFR Part 820 / Part 11 as applicable)
•    International Organization for Standardization standards (e.g., ISO 13485) and Internal Quality Management System (QMS) procedures
•    Maintain accurate, organized, and audit-ready records

Cross-Functional Collaboration: work closely with Manufacturing and Quality teams to gather input and execute tasks
•    Communicate progress, issues, and risks to project leads
•    Participate in team meetings and provide updates on assigned activities

Deliverables: Updated validation protocols and reports
•    Completed test execution records and supporting data
•    Documented gap assessments (as assigned)
•    Traceability updates and supporting documentation
•    Inputs to remediation plans and progress tracking
What you will bring
•    Bachelor’s degree in engineering coupled with eight plus years of manufacturing engineering experience
•    Advanced computer skills including MS Office applications (Word/Excel/PowerPoint/Project/Visio)
•    Proficient in the use of Minitab statistical analysis
•    Experience with SolidWorks, ProE or Inventor, prototypes, 3D (desirable)
•    Familiar with electronic management documentation

ECI is an equal opportunity employer.

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.