Manufacturing Engineer — NPI & Process Excellence

Keystone Distinction Group

Indianapolis (IN)

On-site

USD 80,000 - 110,000

Full time

14 days+

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Job summary

Keystone Distinction Group is seeking a Manufacturing Engineer to develop, validate, and optimize electronics and mechanical assembly processes. You will lead NPI transfers, document procedures, and implement improvements to safety, quality, and cost.

Cross-functional collaboration with engineering, quality, and production teams is essential. The role requires hands-on problem solving, strong communication, and a track record with lean manufacturing, six sigma, and process validation in a

Qualifications

  • Minimum 5 years of Manufacturing Engineering experience in a production environment.
  • Medical device manufacturing experience required.
  • Experience supporting mixed electronics and mechanical assembly manufacturing operations.
  • Hands-on experience with assembly processes including soldering, epoxy application, tooling, fixtures, and manufacturing equipment.
  • Experience with process validation, process control, and manufacturing documentation systems.
  • Proven success leading continuous improvement and cost reduction initiatives.
  • Experience supporting high-volume manufacturing environments preferred.
  • ITAR: U.S. persons or protected individuals per ITAR requirements.

Responsibilities

  • Analyze and optimize manufacturing processes to improve production efficiency, quality, safety, and cost performance.
  • Develop, document, validate, and maintain manufacturing procedures, work instructions, process flows, and engineering documentation.
  • Lead continuous improvement initiatives utilizing Lean Manufacturing, Six Sigma, Kaizen, 5S, SPC, and other operational excellence methodologies.
  • Perform root cause analysis, failure investigations, and implement corrective and preventive actions (CAPA) to resolve manufacturing and quality issues.
  • Design, develop, and implement manufacturing fixtures, tooling, and assembly processes for electronics and mechanical assemblies.
  • Support assembly operations involving soldering, epoxy dispensing, electromechanical assembly, and related manufacturing processes.
  • Collaborate with production, quality, supply chain, engineering, vendors, and customers to resolve technical issues and improve manufacturing performance.
  • Establish process controls, collect and analyze production data, develop labor standards, and monitor key manufacturing metrics.
  • Support installation, qualification, and validation of new manufacturing equipment and capital projects.
  • Lead new product introduction (NPI) activities, ensuring successful transfer of products from design into production.

Skills

Lean Manufacturing
Six Sigma
APQP
PFMEA
Control Plans
SPC
MSA
CAPA
Root Cause Analysis
IQ/OQ/PQ
Automation
Equipment Integration
ERP/MRP
Production Planning
CAD
SolidWorks
Statistical Analysis
Microsoft Office
Problem Solving
English Proficiency
Interpersonal Skills

Education

BS in Manufacturing Engineering
BS in Mechanical Engineering
BS in Industrial Engineering
Related technical discipline

Tools

CAD
SolidWorks

Job description

Keystone Distinction Group is seeking a Manufacturing Engineer to develop, validate, and optimize electronics and mechanical assembly processes. You will lead NPI transfers, document procedures, and implement improvements to safety, quality, and cost.

Cross-functional collaboration with engineering, quality, and production teams is essential. The role requires hands-on problem solving, strong communication, and a track record with lean manufacturing, six sigma, and process validation in a

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