Manufacturing Engineer I: Med Device Design Transfer

DiaSorin; Austin (TX); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Paid time off

Annual incentive program

Job summary

Diasorin, a global leader in diagnostics, seeks a Manufacturing Engineer‑Level I to support instrument and consumable manufacturing in ISO 13485 and FDA regulated settings. You will interface with design teams, drive transfer activities, and own process validation planning for new products.

The role requires a Bachelor’s in engineering and 5+ years in process improvement with strong cross‑functional collaboration, documentation, and problem solving. Onsite in Austin, TX with travel as needed.

Qualifications

• Bachelor's degree in a relevant engineering field is required.
• Minimum 5+ years in process improvement and sustaining engineering in regulated life sciences.
• Experience with ISO 13485 and FDA Quality System requirements.
• Strong knowledge of PLM, ERP and engineering change control processes.
• Proven analytical, documentation, and cross‑functional collaboration skills.

Responsibilities

• Provide direct technical support for instruments and consumables in ISO 13485/FDA environments.
• Lead design transfer ownership and production release activities for new or on‑market products.
• Collaborate with R&D on development and qualification of processes and test methods.
• Drive sustaining engineering initiatives to improve quality, safety and throughput.
• Support audits, CAPA, and change control activities with thorough documentation.

Skills

Excellent communication skills

Data analysis

Technical writing

MS Office proficiency

Education

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

Tools

PLM

ERP

Engineering Change Control

Job description

Diasorin, a global leader in diagnostics, seeks a Manufacturing Engineer‑Level I to support instrument and consumable manufacturing in ISO 13485 and FDA regulated settings. You will interface with design teams, drive transfer activities, and own process validation planning for new products.

The role requires a Bachelor’s in engineering and 5+ years in process improvement with strong cross‑functional collaboration, documentation, and problem solving. Onsite in Austin, TX with travel as needed.