Manufacturing Engineer - Level I

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

Manufacturing Engineer - Level I

Published on: Sep 2, 2026

Country: United States

Location: Austin, Texas

Company: Luminex Corporation

Job Category: Operations

Employment type: Regular Full Time

Req ID: 7791

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry's broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

Why Join Diasorin

• Build What Matters
  Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale
  Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People-Centered Culture
  Thrive in a culture that values accountability, inclusion, and continuous development.

Job Scope

The Manufacturing Engineering, Level 1 will be responsible for direct technical support for Instruments and Consumable Manufacturing operations in ISO 13485 and FDA regulated medical device setting. Representing Operations in design teams for new and on market product design and development, design transfer, and market phases. Facilitating in the definition of project tasks, establishing timelines, and fulfilling responsibilities for product design transfer and related process engineering. Collaborating on the development and assuming full ownership at Production release of material specifications/drawings, manufacturing processes, repair/refurb processes, fixtures, test methods, analysis tools, and related acceptance criteria for new or on market product. Leading and assisting in product, supplier, and process sustaining engineering initiatives to scale manufacturing throughput and improve quality, compliance, safety, yields, efficiency, reliability, and cost. Facilitating the investigation and resolution of findings identified through audits, non-conformances, corrective/preventative actions, or customer complaints. Task-specific and change control training of Manufacturing personnel.

Key Duties and Responsibilities

• Represent Operations in design teams; 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 support obsolescence management.
• Lead or assist in product, supplier, and process sustaining engineering initiatives to improve quality, compliance, safety, efficiency, reliability, cost, and scale throughput.
• Provide technical support for supplier issues
• Participate and drive development and implementation of process automation strategies and solutions
• Lead and assist in engineering change control and document change control activities; participate in change control reviews.
• Collaborate with R&D on development and assume full design transfer ownership for Production and Market release of material specifications/drawings, manufacturing processes, repair/refurb processes, fixtures, test methods, analysis tools, work instructions and related acceptance criteria for new or on market product.
• Establish and maintain standard architecture of BOMs and routings
• Collaborate with R&D on OQ process validation planning and execution. Assume full ownership of PQ process validation planning, execution, and reporting.
• Assume full ownership of equipment, test fixture, test method, analysis tool validation planning, execution, and reporting; collaborate with R&D as required.
• Ensure effective training of Manufacturing and Quality Control personnel for transfer of new processes.
• Assist the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation.
• Participate in or conduct applicable departmental, interdepartmental and intra-departmental training.
• Ensure personal compliance and promote operational compliance with the Quality System and other regulations.
• Ensure compliance to NFPA, OSHA, lock-out, and other applicable safety standards.

Education, Experience, and Qualifications

• Bachelor's Degree Bachelors of Science in the field of Mechanical, Electrical, Industrial, Bio‑medical, or Biomechanical Engineering. required
• 5+ Years Experience and technical leadership supporting process improvement and sustaining engineering in a ISO 13485 and/or FDA regulated Life Sciences, Medical Device, or Medical Technology industry. preferred
• 1+ Years Experience working independently or as a team member in a fast‑paced environment with rapidly changing priorities preferred
• Thorough knowledge of ISO 13485 and FDA Quality System requirements
• Knowledge of Enterprise Resource Planning, including applied knowledge of engineering functionality
• Proficiency in the use of Product Lifecycle Management, including applied knowledge of Engineering Change Control
• Applied knowledge of Process and Test Method Validations as required by FDA Quality System guidelines
• Knowledge of Design Control requirements as defined by the FDA Quality System guidelines
• Proven results through application of Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments
• Mathematics and statistics aptitude.
• Data analysis and technical writing aptitude.
• Excellent oral and written communication skills.
• Proficient in Microsoft Word, Excel, and PowerPoint programs.
• Highly organized with proven time management and prioritization skills
• Ability to work independently and with minimal supervision
• Ability to handle the pressure of meeting tight deadlines

Standard Working Conditions

• Work is typically performed in an office environment. - Frequently
• Possible exposure to mechanical, biological, and chemical hazards. - Frequently
• Possible exposure to Chemicals, Lasers, Excessive Noise, etc. - Frequently
• Work in manufacturing setting which may include BioSafety Level 2 areas; work may be performed in fume hood, clean hood, biosafety cabinet, and/or ISO Class 7 cleanroom with specialized gowning and safety requirements - Frequently
• Work in walk‑in refrigerators and freezers that encompass conditions down to -20C - Frequently

Travel Requirements

• Travel may be required at least 10% of the time

What we offer

Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact [e-mail].

Nearest Major Market:

Austin