Launch Quality Engineer - NPI & Process Readiness

Engineered-Medical-Systems,-LL; Bartlett (TN); On-site; USD 90,000 - 130,000; Full time

Job summary

Engineered-Medical-Systems,-LL seeks a Launch Quality Engineer to support new product introductions, ensuring designs are manufacturable and meet critical feature inspection criteria. You will work with Manufacturing Engineering and Account Management teams to translate customer requirements into tools for operations and to drive timely, conforming part production.

This role focuses on first article inspections, DHR package readiness, and continuous improvement within an FDA-regulated ISO 13485

Qualifications

• University degree or extensive practical experience (4+ years).
• Medical device manufacturing experience preferred.
• Experience in a precision machining environment preferred.
• CQE preferred.
• Knowledge of current statistical and analytical methods.
• Knowledge of manufacturing documentation.
• Manufacturing engineering in an FDA-regulated environment preferred.
• Ability to read/understand engineering drawings in common software preferred.
• Experience using Lean tools/principles preferred.
• Must be able to speak, read, and write in English.

Responsibilities

• Review customer prints for gaps in alignment between components and inspect critical features and inspection methods.
• Clarify and align customer expectations regarding critical feature inspection, data reporting, gaging needs/ownership/responsibility, and MSA requirements.
• Identify need for off-the-shelf or custom gaging and readiness impact to part production.
• Identify and facilitate programming of advanced inspection tools and readiness impact to part production.
• Identify alternate inspection methods to mitigate negative impact on part production.
• Clarify and align customer expectations regarding process capability requirements and facilitate data collection.
• Collaborate with MEs, the Programming team, and other machining/ setup experts to align features to process steps and develop inspection criteria.
• Develop inspection criteria for finish line processes such as metal finish, laser marking, in-process and final inspection.
• Ensure all inspection criteria incorporate customer requirements.
• Support the NPI team to build and deliver a fully executable DHR package to plant floor operations.
• Collaborate with plant floor and engineering support to execute/ facilitate first article inspections.
• Analyze pre-production, launch, and launch+1 runs for feedback with EMS and customer.
• Manage complaint investigations and CAPA for products in the NPI process.
• Execute Contract Review Checklists, Quality Engineering Workbook builds, and Certificate of Conformance packets for NPI orders through Launch+1.
• Execute First Article package preparation and inspections as needed.
• Maintain partnership with EMS SQE regarding NPI status.
• Support evolving process capability efforts for VMI and Cellular Manufacturing.
• Support complaint investigations and CAPA for post-NPI products.
• Support customer visits/calls for periodic quality/nonconformance reviews and business reviews.
• Support EMS Quality Policy and Objectives.
• Perform Other Duties as assigned.

Skills

Statistical methods

Lean principles

Reading engineering drawings

English communication

Education

University degree (related field)

Job description

Engineered-Medical-Systems,-LL seeks a Launch Quality Engineer to support new product introductions, ensuring designs are manufacturable and meet critical feature inspection criteria. You will work with Manufacturing Engineering and Account Management teams to translate customer requirements into tools for operations and to drive timely, conforming part production.

This role focuses on first article inspections, DHR package readiness, and continuous improvement within an FDA-regulated ISO 13485