NPI Quality Engineer — Launch & Inspection Lead

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

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