Engineer – Supplier Engineering

Engineer – Supplier Engineering

Requirements

• BS Engineering degree (Mechanical, Manufacturing/Industrial, BioMedical, Chemical, Plastics)
• 3+ years manufacturing experience required

Responsibilities

• Lead, manage, and execute systematic root cause investigation efforts on the manufacturing floor.
• Execute site-specific assembly validations of new supplier tooling. Author validation reports and process through product lifecycle management portal.
• Identify, justify, and implement continuous improvement projects related to component assembly.
• Maintain within-hours response time to Operations team component escalations.
• Assist in the containment, investigation, corrective and preventive action of quality issues relating to supplier parts.
• Establish and maintain relationship with tier 1 suppliers; communicate opportunities for continuous improvement in supplier processes.
• Lead and influence cross-functional teams toward continuous improvement goals.

Preferred Qualifications

• High volume medical device experience in a cGMP environment strongly preferred
• Proven track record using common root cause analysis & process improvement tools (A3, 8D, Fishbone, 5 Why, DOE, regression, etc.)
• Experience with at least 3 of the following manufacturing processes: injection molding, sheet metal stamping, spring forming, PCBA, automated assembly/packaging
• Validation experience in the context of a highly regulated environment i.e. IQ/OQ/PQ
• Strong statistical competency in popular softwares (minitab, JMP)
• Mechanical drawing literacy, knowledge of basic GD&T callouts (run-out, true position, etc), working knowledge of tolerance stack analysis, novice-intermediate solidworks experience
• Strong Written and Verbal communication skills
• Lean Six Sigma Green Belt with relevant projects preferred