Manufacturing Engineer - Scientist I

TL;DR

Manufacturing Engineer - Scientist I: Representing Operations in design teams and owning design transfer and production/market release for material specifications, manufacturing processes, test methods, analysis tools, and work instructions with an accent on FDA/ISO 13485-aligned validation, stability programs, and change control. Focus on sustaining engineering improvements, investigating nonconformances and customer complaints, and ensuring training and compliance for manufacturing and QC in a regulated life-sciences environment.

Company

hirify.global is a global leader in immunodiagnostic and molecular diagnostic solutions.

What you will do

• Represent Operations in design teams for new and on-market product development, design transfer, validation, and market release phases.
• Own production and market release of material specifications, manufacturing processes, test methods, analysis tools, work instructions, and acceptance criteria.
• Lead and support sustaining engineering projects for process, cleaning, stability methods, test methods, specifications, equipment/fixtures, analysis tools, and enterprise systems.
• Develop and oversee product stability plans, protocols, and reports; support stability study execution and training.
• Drive engineering change control and document change control activities; participate in change control reviews.
• Investigate and resolve audit findings, non-conformances, CAPA, and customer complaint escalations; support process automation strategies and statistical process control.

Requirements

• Bachelor’s degree (B.S. or advanced degree) in Chemistry/Chemical Engineering, Microbiology, Life Sciences, or Biomechanical Engineering.
• 5+ years of reagent Operations experience in an ISO 13485 and/or FDA-regulated setting (preferred).
• 2+ years of experience in process improvement, sustaining engineering, and/or design transfer in life sciences/chemistry/biomechanical engineering/medical technology (preferred).
• Thorough knowledge of ISO 13485 and FDA Quality System requirements; applied knowledge of ERP, PLM, engineering change control, and FDA-aligned process/test method validations and design control.
• Proven results using Six Sigma and Lean Manufacturing, including statistical design of experiments; strong math/statistics, data analysis, and technical writing skills.
• Must work onsite at the Luminex office (Austin, Texas).

Culture & Benefits

• Competitive salary and benefits package.
• People-centered culture emphasizing accountability, inclusion, and continuous development.
• Operational excellence and customer focus in a regulated diagnostics environment.
• Training and knowledge transfer for manufacturing and QC personnel during process and design transfers.

Hiring process

• Application submission through the company careers portal.
• Employment eligibility verification and possible background check/drug screening where permitted by law.

Location: Onsite at Luminex office, Austin, Texas, United States