Launch Quality Engineer

Engineered Medical Systems•Bartlett, TN

26d•Onsite

About The Position

This team member supports various activities that contribute to the overall EMS objective of compliance with FDA regulations and ISO 13485 requirements. Ongoing collaboration with additional EMS roles is required.

Requirements

4+ years of related experience required.
Knowledge of current statistical and analytical methods.
Knowledge of manufacturing documentation.
Must be able to speak, read, and write in the English language

Nice To Haves

University degree, or an extensive amount of practical knowledge gained through experience.
Experience in Medical Device Manufacturing preferred.
Experience in a precision machining environment preferred.
CQE preferred.
Manufacturing engineering in an FDA-regulated environment is preferred.
Ability to read/understand engineering drawings on common engineering software is preferred.
Experience using or understanding Lean tools/principles is preferred.

Responsibilities

Review customer prints for gaps in alignment between components that could impede device function and inspect the ability of critical features and potential inspection methods.
Clarify and align customer expectations regarding critical feature inspection, data reporting, gaging needs/ownership/responsibility, and MSA requirements.
Develop and facilitate the execution of GR&Rs as needed.
Identify the need/potential for procurement of off-the-shelf or custom gaging and readiness impact to part production.
Identify the need/potential 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.
Facilitate data collection and execute calculations as needed.
Collaborate with MEs, the Programming team, and others with relevant machining and set-up experience to understand the alignment of features to process steps and execute/facilitate inspection criteria development for plant floor operations.
Execute/facilitate the development of inspection criteria for appropriate finish line process steps such as metal finish, laser marking, in-process inspection, and final inspection.
Ensure all inspection criteria incorporate customer requirements as appropriate
Support the NPI team to build & deliver a fully executable DHR package to plant floor operations.
Collaborate with appropriate plant floor and engineering support personnel to execute/facilitate/analyze the first article or first piece inspection at relevant production operations to ensure planned process steps, controls, and outcomes are fully executable or need further improvement.
In collaboration with other NPI team members, execute or facilitate analysis of any pre-production, launch, and launch+1 runs for feedback to support both EMS and customer improvement opportunities.
Manage complaint investigations and corrective and preventive action efforts of products active in the NPI process.
Execute Contract Review Checklists, Quality Engineering Workbook builds, and Certificate of Conformance packet builds for all NPI-related orders through Launch+1.
Execute First Article package preparation and compilation for all NPI-related orders as required.
Facilitate, coordinate, or execute First Article inspections as needed.
Maintain collaborative partnership with EMS Sustaining Quality Engineers (SQE) regarding the status of NPI projects.
Support SQE with evolving process capability efforts to improve efficiency and evolving criteria for Vendor-Managed Inventory and Cellular Manufacturing opportunities.
Support complaint investigations and corrective and preventive action efforts, especially when related to product that is post-NPI.
Support engagement with customer visits/calls related to periodic quality/nonconformance reviews and business reviews.
Support the EMS Quality Policy and Quality Objectives.
Perform Other Duties as assigned.