Senior Manufacturing Engineer - Medical Device Transfer

About the role

ECI, a professional consulting firm for the life sciences industry, is looking for a Senior Manufacturing Engineer to provide technical leadership and manufacturing engineering support throughout the transfer lifecycle of a medical device project. The role covers the transfer of manufacturing processes from the source location to the receiving manufacturing site.

Key responsibilities

• Support the assessment and transfer of manufacturing processes from the source to the receiving site.
• Review manufacturing documentation such as process specifications, work instructions, drawings, bills of materials and equipment requirements.
• Identify process gaps, risks and opportunities for improvement.
• Develop and run manufacturing engineering activities to establish production readiness, and support equipment, tooling, fixtures and line readiness.
• Support process development, optimization and troubleshooting, and define or support process requirements, methods and production controls.
• Take part in PFMEA, process flow, control plan and risk assessment activities, and support process validation and qualification, including protocol and report review.
• Provide technical support during engineering builds, pilot builds and production readiness activities, and support root cause investigations and corrective actions.
• Evaluate process capability and performance, support training and knowledge transfer, and identify improvements to manufacturability, yield, cycle time, quality and robustness.
• Support engineering change implementation, documentation updates, project risk assessments and transfer readiness reviews.

Required profile

• Bachelor's degree in Engineering.
• 8 years of experience.
• Injection molding experience is desirable.
• Native Spanish speaker, fluent English speaking, writing and reading.

Required skills

• Advanced computer skills with MS Office (Word, Excel, PowerPoint, Project, Visio).
• Proficiency in Minitab statistical analysis.
• Experience with SolidWorks, ProE or Inventor, prototypes and 3D printing is desirable.
• Familiarity with electronic management documentation.