Manufacturing Engineer I - Medical Devices

DiaSorin; Town of Texas (WI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Annual incentive program

Job summary

Diasorin is seeking a Manufacturing Engineer, Level I, to join our Austin, TX site. You will support instruments and consumables manufacturing under ISO 13485 and FDA-regulated environments, partnering with R&D on design transfer and production release, and driving process improvements for quality, safety, and throughput.

You will own sustaining engineering for on-market products, engage in automated process solutions, and contribute to scalable manufacturing while ensuring compliance with

Qualifications

• Bachelor's degree required in Mechanical, Electrical, Industrial, Bio-medical, or Biomechanical Engineering.
• 5+ years experience in ISO 13485 / FDA regulated life sciences or medical device industries.
• Experience with sustaining engineering and design transfer processes.

Responsibilities

• Represent Operations in design teams and fulfill design transfer responsibilities for new and on-market product development, validation, and market release phases.
• Assume full ownership of sustaining engineering support for on-market products.
• Lead or assist in sustaining engineering initiatives to improve quality, safety, reliability, and cost.
• Provide technical support for supplier issues and process automation implementations.
• Lead engineering change control and document change control activities; participate in reviews.
• Collaborate with R&D on design transfer ownership for Production and Market release.

Skills

Process improvement

Sustaining engineering

Project management

Six Sigma

Lean manufacturing

Data analysis

Technical writing

Communication skills

Education

Bachelor's Degree in Mechanical, Electrical, Industrial, Bio-medical, or Biomechanical Engineering

Tools

ERP systems

PLM (Product Lifecycle Management)

Engineering Change Control (ECC)

MS Office (Word, Excel, PowerPoint)

Job description

Diasorin is seeking a Manufacturing Engineer, Level I, to join our Austin, TX site. You will support instruments and consumables manufacturing under ISO 13485 and FDA-regulated environments, partnering with R&D on design transfer and production release, and driving process improvements for quality, safety, and throughput.

You will own sustaining engineering for on-market products, engage in automated process solutions, and contribute to scalable manufacturing while ensuring compliance with