Launch Quality Engineer

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

The Launch Quality Engineer (LQE) focuses specifically on supporting new product introductions (NPI). The LQE is a member of an EMS NPI team that includes representatives from Manufacturing Engineering (ME) and Account Management (AM). The LQE and their team work directly with customer teams to ensure new product designs are assessed for manufacturability, risks to the desired function, critical feature inspection correlation, and other deliverables. The LQE is also responsible for ensuring that all customer requirements are fully and appropriately translated into the necessary tools for operations to achieve timely and conforming part production successfully.

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.

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

• This role typically requires a university degree, or an extensive amount of practical knowledge gained through experience. 4+ years of related experience required.
• Experience in Medical Device Manufacturing 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 is preferred.
• Ability to read/understand engineering drawings on common engineering software is preferred.
• Experience using or understanding Lean tools/principles is preferred.
• Must be able to speak, read, and write in the English language

Restrictions

• Good vision either natural or through correction (Glasses/Contacts lens) is needed for this position.
• Levels of Monochromacy, also known as Color Blindness, must be known to establish appropriate risk for certain types of inspection that are dependent on color recognition.
• Ability to bend, stoop, grip, reach, and lift up to 40 lbs.

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