Sr Engineering Consultant - Process Development - Medical Device #4037

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

This role primarily supports design development activities from a documentation perspective, ensuring accurate and timely updates to the Design History File, including Design Inputs/Outputs, Verification and Validation, Risk Management, and CAPA/NC. It involves working closely with cross-functional teams to gather, organize, and maintain technical documentation, while providing clear communication to stakeholders and supporting overall project compliance and traceability.

What you'll do

• Review the following documentation and perform a gap analysis:
• • Bill of Materials (BOMs)
  • Complaints
  • Design Matrix
  • Design Validation protocols and reports
  • Design Verification protocols and reports
  • Incoming Inspections
  • Lists of Applicable Standards
  • Manufacturing Tools
  • Preventive Maintenance
  • Process Validation protocols and reports
  • Product Drawings
  • Production Methods
  • Risk Management documents
  • Test Methods and Test Method Validations
  • Tolerance Analysis
  • Usability documents
  • User Needs and Design Requirements documents
• Prepare and maintain a Project Tracker with weekly updates for Management Review.
• Knowledge transfer to client during and at completion of the project.
• Other tasks as agreed upon between the Liaisons listed in this Statement of Work.

What you will bring

• Bachelor’s Degree in Engineering.
• 8 year of 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.
• Familiar with electronic management documentation.
• Spanish: Native Speaker, English: Fluent speaking, writing and reading.

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.

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future.  At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity. 

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