Manufacturing Engineering Consultant II #1664

Brief DescriptionAbout ECIECI’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 This RoleThe Manufacturing Engineering Consultant will enhance production processes to ensure efficiency, quality, and safety. This role requires collaboration with cross-functional teams, strong problem-solving abilities, and a deep understanding of manufacturing systems to drive success. This role is an onsite role.What You'll DoWhat You'll Do Understanding of the Manufacturing Process: Review current process flows, control plans, PFMEAs, and manufacturing instructions. Conduct line assessments and provide observations. Assess current state of each critical process and identify deviations or inefficiencies for review. Identification and Analysis of Rework Activities: Map and analyze rework stations and rework flow within the manufacturing lines. Quantify rework frequency, causes, and impacted products. Evaluate rework effectiveness and documentation practices. Collaborate with Quality and Operations to identify root causes for rework and its effect on product quality and compliance. Update and Author Manufacturing Documentation: Update manufacturing work instructions, graphical operating instructions (GOIs), and visual aids based on updated processes. Ensure all changes follow appropriate Windchill change control procedures. Support training of operators on updated instructions. Compliance and Risk Management: Ensure remediation efforts align with applicable regulatory requirements (FDA 21 CFR 820, ISO 13485). Update risk management documentation (e.g., pFMEAs and/or PFAS) based on identified issues and implemented fixes. Ensure traceability and documentation integrity during and after remediation efforts.What We're Looking ForBachelor’s Degree in Engineering.5 – 7 years 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 (desirable)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. Manufacturing Process ImprovementProduct