Manufacturing Engineer

Talent 1 Source; Indianapolis (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Talent 1 Source in Indianapolis, IN is seeking a Manufacturing Engineer to develop, validate, and optimize electronics and mechanical assembly processes. You will support NPI, process development, and continuous improvement to boost productivity, quality, safety, and cost efficiency.

This role requires 5+ years in manufacturing engineering, experience with ISO 9001/13485, soldering and fixtures, and hands-on automation. A Bachelor’s degree in a related field is required.

Qualifications

• Minimum 5 years of Manufacturing Engineering experience in production environments.
• Medical device manufacturing experience is not required here; electronics/mechanical assembly background is relevant.
• Hands-on with soldering, tooling, fixtures, and assembly workstations.
• Experience with process validation and documentation systems.
• Experience leading continuous improvement and cost-reduction initiatives.
• Ability to work in a high-volume manufacturing setting and cross-functional teams.

Responsibilities

• Analyze and optimize manufacturing processes to improve production efficiency, quality, safety, and costs.
• Develop, document, validate, and maintain manufacturing procedures, work instructions, and process flows.
• Lead continuous improvement initiatives using Lean, Six Sigma, Kaizen, 5S, SPC, and CAPA.
• Perform root cause analysis and implement corrective actions to resolve issues.
• Design and implement fixtures, tooling, and assembly processes for electronics and mechanical assemblies.
• Support soldering, epoxy dispensing, electromechanical assembly, and related processes.
• Collaborate with production, quality, supply chain, engineering, vendors, and customers.
• Establish process controls, analyze production data, and monitor KPIs.
• Support installation, qualification, and validation of new equipment and capital projects.
• Lead NPI activities and ensure smooth transfer from design to production.

Skills

Lean Manufacturing

Six Sigma

PFMEA

Control Plans

CAPA

Root Cause Analysis

IQ/OQ/PQ

Automation

ERP/MRP

CAD

SolidWorks

English Proficiency

Interpersonal Skills

Education

Bachelor of Science in Manufacturing Engineering

Tools

SolidWorks

ERP/MRP

Job description

Indianapolis, United States

The Manufacturing Engineer is responsible for developing, implementing, validating, and

optimizing manufacturing processes for electronics and mechanical assembly operations. This

role supports new product introduction (NPI), process development, and continuous

improvement initiatives to enhance productivity, product quality, worker safety, and cost

efficiency. The Manufacturing Engineer provides technical leadership and hands on support to

manufacturing operations through process control, root cause analysis, tooling and fixture

development, automation projects, and compliance with quality management systems. Working

cross-functionally with engineering, quality, supply chain, and production teams, this position

ensures robust, scalable, and efficient manufacturing processes that support business

objectives and customer requirements.

What you'll need and what you'll be doing:

• Effective interpersonal and team leadership skills.
• Able to solve complex problems.
• Good verbal and written communication skills.
• Sound judgement and decision making.
• Ability to communicate and implement change.

Job Duties and 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.

Job Description

Manufacturing Engineer

• Develop and maintain APQP documentation including Process Flow Diagrams (PFD), PFMEA, Control Plans, MSA studies, and process validation protocols.
• Conduct capability studies and equipment/process qualifications including IQ, OQ, and PQ activities.
• Support compliance with ISO 9001, ISO 13485, and applicable regulatory requirements.
• Identify and implement automation solutions to improve manufacturing throughput, consistency, and product quality.

Requirements

• 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.
• This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR). This position requires individuals who are U.S. persons or protected individuals within the meaning of ITAR. ITAR defines U.S. persons and protected individuals as a U.S. Citizen, U.S. Permanent Resident (i.e., 'Green Card Holder'), U.S. Temporary Resident, Political Asylee, or Refugee.

Skills

• Lean Manufacturing and Six Sigma methodologies.
• APQP, PFMEA, Control Plans, SPC, MSA, CAPA, and Root Cause Analysis.
• Process validation methodologies including IQ/OQ/PQ.
• Manufacturing automation and equipment integration.
• ERP/MRP systems and production planning tools.
• CAD software experience; SolidWorks preferred.
• Statistical analysis and process capability evaluation.
• Strong problem-solving capabilities.
• Proficient in English (reading, writing & verbal skills)
• Effective interpersonal skills to drive tasks to completion

Education

• Bachelor of Science in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related technical discipline

Questions

• Have you supported electromechanical or electronicsassembly processes?
• Have you worked with soldering, epoxy dispensing,potting, bonding, fixtures, tooling, or assembly workstations?
• Have you led NPI transfer from design intoproduction?
• Have you created PFMEAs, control plans, processflows, work instructions, and validation protocols?
• Have you worked with IQ/OQ/PQ or process validation?
• Have you worked under ISO 9001 or ISO 13485?
• Have you solved a manufacturing problem using rootcause/CAPA?
• Have you supported automation orequipment-integration projects?
• Have you experience with CAD tools, especiallySolidWorks?