Manufacturing Engineer - Level I

Select how often (in days) to receive an alert: Manufacturing Engineer - Level I Published on: Jun 2, 2026 Country: United States Location: Austin, Texas Company: Luminex Corporation Job Category: Operations Employment type: Regular Full Time 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 -20°C - Frequently Travel Requirements Travel may be required at least 10% of the time What we offer Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world. 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, or protected veteran status, and will not be discriminated against on the basis of disability. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at View email address on click.appcast.io or View phone number on click.appcast.io to request an accommodation. The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department. #J-18808-Ljbffr DiaSorin