Senior Engineer, Manufacturing

About the position

The Senior Manufacturing Engineer will support the ICU Manufacturing Engineering Department and report to the Manufacturing or Product Engineering Manager. The Senior Manufacturing Engineer is responsible for owning and driving process improvements through adherence to established design control processes, good engineering and documentation practices. The key responsibility of this position is to exercise judgement and take action while adhering to defined procedures during project support & improvements.

Responsibilities

• Initiate and manage projects with adherence to program-management guidelines
• Own and manage CAPA tasks and deliverables (Corrective and Preventive)
• Lead vendor assessment and review of materials/machine technical information
• Identify and implement process and product modifications to improve manufacturability and impact on automation equipment
• Consult with Product and Molding Engineers on in-process non-conformances
• Process technical expert for multiple manufacturing production lines
• Create and edit documents to support Production
• Work with Quality Engineers on qualification activities for new or modified processes and equipment
• Spearhead initiatives for continuous process improvements
• Develop a broad understanding from start to end of the product manufacturing process in the company
• Perform design assessments, active participation in design reviews and risk management processes
• Network with senior internal and external personnel

Requirements

• Substantial knowledge in one or more key process areas: automation, medical-device assembly or controls
• Understanding of strength of materials, plastic injection molding, fixturing, testing, and process control techniques
• Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.)
• Knowledge of the Medical Device Industry and familiarity with FDA QSR regulation
• Solid works knowledge to interpret part dimensions, sectional views, conduct mates and build assemblies
• Technical writing competency
• Bachelor's degree from an accredited college or university in STEM discipline
• 7+ years' experience