Manufacturing Engineer - Level I (Medtech)

TL;DR

Manufacturing Engineer - Level I (Medtech): Providing technical support for instrument and consumable manufacturing operations within ISO 13485 and FDA regulated environments with an accent on design transfer and process engineering. Focus on scaling manufacturing throughput, improving quality and compliance, and leading sustaining engineering initiatives for on-market products.

Location: Onsite in Austin, Texas, United States

Company

Global leader in immunodiagnostic and molecular diagnostic solutions advancing science to improve patient outcomes worldwide.

What you will do

• Represent Operations in design teams for new and on-market product development, validation, and market release.
• Own sustaining engineering support and obsolescence management to improve quality, safety, and cost.
• Develop and manage material specifications, drawings, manufacturing processes, and test methods.
• Lead PQ process validation and the validation of equipment, test fixtures, and analysis tools.
• Drive engineering and document change control activities and provide technical training to manufacturing personnel.
• Investigate and resolve findings from audits, non-conformances, and customer complaints.

Requirements

• Bachelor's degree in Mechanical, Electrical, Industrial, Bio-medical, or Biomechanical Engineering.
• Must be based in or able to work onsite in Austin, Texas.
• Thorough knowledge of ISO 13485 and FDA Quality System requirements.
• Proficiency in Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems.
• Applied knowledge of Six Sigma, Lean Manufacturing, and statistical design of experiments.
• Strong technical writing, data analysis, and communication skills.

Nice to have

• 5+ years of experience in ISO 13485/FDA regulated Life Sciences or Medical Device industry.
• 1+ years of experience working in fast-paced environments with rapidly changing priorities.

Culture & Benefits

• Competitive salary and benefits package.
• People-centered culture that values accountability, inclusion, and continuous development.
• Entrepreneurial environment enabling speed, collaboration, and global impact.
• Opportunity to take ownership and contribute to solutions that improve global patient care.