Manufacturing Engineer

Manufacturing Engineer

This is an engineering company operates a medical device manufacturing facility that combines electronics and mechanical assembly operations. The organization is looking for a Manufacturing Engineer to lead process development, new product introduction, and continuous improvement work across production. This role works cross functionally with quality, supply chain, and production teams to keep manufacturing processes efficient, compliant, and scalable.

Full time.

$80,000 to $105,000 per year, depending on experience.

What You'll Do

In this role, you will analyze and optimize manufacturing processes to improve production efficiency, quality, safety, and cost performance, while developing and maintaining manufacturing procedures, work instructions, process flows, and engineering documentation. You will lead continuous improvement initiatives using Lean Manufacturing, Six Sigma, Kaizen, 5S, and SPC methodologies, and perform root cause analysis and failure investigations, implementing corrective and preventive actions to resolve manufacturing and quality issues.

You will design, develop, and implement manufacturing fixtures, tooling, and assembly processes for electronics and mechanical assemblies, supporting operations involving soldering, epoxy dispensing, and electromechanical assembly. You will collaborate with production, quality, supply chain, engineering, vendors, and customers to resolve technical issues, establish process controls, collect and analyze production data, develop labor standards, and monitor key manufacturing metrics.

You will support installation, qualification, and validation of new manufacturing equipment and capital projects, and lead new product introduction activities to ensure successful transfer of products from design into production. This includes developing and maintaining APQP documentation such as Process Flow Diagrams, PFMEA, Control Plans, and MSA studies, along with conducting capability studies and IQ, OQ, and PQ qualifications. You will support compliance with ISO 9001 and ISO 13485, and identify automation solutions to improve manufacturing throughput, consistency, and product quality.

Required Qualifications

• Bachelor of Science in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or related technical discipline
• Minimum 5 years of Manufacturing Engineering experience in a production environment
• Medical device manufacturing experience
• Experience supporting mixed electronics and mechanical assembly manufacturing operations
• Hands on experience with soldering, epoxy application, tooling, fixtures, and manufacturing equipment
• Experience with process validation, process control, and manufacturing documentation systems
• Due to ITAR regulations, candidates must qualify as a U.S. Citizen, U.S. Permanent Resident, U.S. Temporary Resident, Political Asylee, or Refugee

Preferred Qualifications

• Experience supporting high volume manufacturing environments
• Six Sigma or Lean Manufacturing certification
• SolidWorks or other CAD software experience
• Experience with ERP/MRP systems and production planning tools

$80,000 to $105,000 per year

Medical, dental, and vision coverage

401(k)

Paid time off

To apply, please submit your resume for consideration.