Launch Quality Engineer

Engineered Medical Systems, LLC; Bartlett (TN); On-site; USD 85,000 - 120,000; Full time

Job summary

Engineered Medical Systems, LLC is seeking a Launch Quality Engineer to support new product introductions (NPI) within the EMS NPI team. The LQE ensures manufacturability, conducts risk assessments, and translates customer requirements into on-the-floor inspection tools and documentation for timely, conforming part production.

The LQE collaborates with Manufacturing Engineering and Account Management, builds GR&R plans, and guides inspection criteria to deliver parts that meet customer specs and

Qualifications

• 4+ years of related experience in medical device manufacturing or QA.
• Experience in a precision machining environment preferred.
• CQE preferred.
• English language proficiency required.

Responsibilities

• Review customer prints for gaps and alignment to device function and inspection methods.
• Develop and facilitate GR&R as needed.
• Identify gaging needs (off-the-shelf or custom) and readiness impact to production.
• Program advanced inspection tools and readiness impact to production.
• Develop inspection criteria for finish line processes and ensure alignment with customer requirements.
• Collaborate with MEs, Programming, and others to map features to process steps and create inspection criteria for plant floor operations.
• Support NPI team to build a complete DHR package for plant floor operations.
• Lead or assist First Article inspections and pre-production/launch runs for continuous improvement.
• Manage investigation of complaints and corrective/preventive actions in NPI context.

Skills

Statistical methods

Manufacturing docs

Lean tools

Reading engineering drawings

Gage/inspection experience

Education

University degree

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.

Please read carefully before applying

I certify that all the information on this application, my resume, or any supporting documents I may present during any interview is and will be true, complete and accurate, to the best of my knowledge. I understand that any falsification, misrepresentation, or omission of any information may result in disqualification from further consideration for employment or, if employed, disciplinary action, up to and including immediate dismissal, regardless of when such information is discovered.

The Company considers this Application for Employment to be a part of the personnel record.

THIS COMPANY IS AN AT-WILL EMPLOYER WHERE ALLOWED BY APPLICABLE STATE LAW. THIS MEANS THAT REGARDLESS OF ANY PROVISION IN THIS APPLICATION, IF HIRED, THE COMPANY OR I MAY TERMINATE THE EMPLOYMENT RELATIONSHIP AT ANY TIME, FOR ANY REASON, WITH OR WITHOUT CAUSE OR NOTICE. NOTHING IN THIS APPLICATION OR IN ANY DOCUMENT OR STATEMENT, WRITTEN OR ORAL, SHALL LIMIT THE RIGHT TO TERMINATE EMPLOYMENT AT‑WILL. I UNDERSTAND THAT NO COMPANY EMPLOYEE OR REPRESENTATIVE HAS THE AUTHORITY TO ENTER INTO A CONTRACT REGARDING DURATION OF TERMS AND CONDITIONS OF EMPLOYMENT OTHER THAN THE PRESIDENT/CEO OF THE COMPANY AND THEN ONLY BY MEANS OF A WRITTEN CONTRACT SIGNED BY THE PRESIDENT/CEO.

I authorize the Company and/or its agents to confirm all statements contained in this application and/or resume as it relates to the position I am seeking, to the extent permitted by federal, state, or local law. Federal law and some states require a separate disclosure and consent when obtaining background reports from a consumer reporting agency. I understand I will be asked to complete any requisite consent forms for the background check which may be required by federal, state and/or local law. I agree to sign these forms and understand that my offer of employment may be conditional upon the background check.

I AUTHORIZE AND CONSENT TO, WITHOUT RESERVATION, ANY PARTY OR AGENCY CONTACTED BY THIS EMPLOYER (INCLUDING ANY AND ALL PRIOR EMPLOYERS OF MINE) TO FURNISH INFORMATION REGARDING MY PREVIOUS EMPLOYMENT HISTORY AND/OR ANY OF THE ABOVE‑MENTIONED INFORMATION. I hereby release, discharge, and hold harmless, to the extent permitted by federal, state, and local law, any party delivering information to the Company pursuant to this authorization from any liability, claims, charges, or causes of action which I may have as a result of the delivery or disclosure of the above requested information. I hereby release from liability the Company for seeking such information and all other persons, corporations, or organizations furnishing such information.

If hired by the Company, I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the United States by this Company as required by the Immigration Reform and Control Act of 1986. I also understand this Company employs only individuals who are legally eligible to work in the United States.