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Diasorin · 1 day ago

Manufacturing Engineer - Level I

Austin, TX

Full-time

Onsite

Mid, Senior Level

5+ years exp

Diasorin is a global leader in diagnostic solutions, dedicated to improving lives through innovative healthcare tools. The Manufacturing Engineer - Level I will provide technical support for manufacturing operations, lead engineering initiatives, and ensure compliance with quality standards in a regulated environment.

BiotechnologyHealth Diagnostics

H1B Sponsor Likely

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

Qualification

ISO 13485 knowledgeFDA Quality System knowledgeProcess validationSix Sigma principlesProduct Lifecycle ManagementData analysisTechnical writingMathematics aptitudeProficient in Microsoft OfficeCommunicationTime managementWork independentlyHandle pressure

Required

Bachelor's Degree Bachelors of Science in the field of Mechanical, Electrical, Industrial, Bio-medical, or Biomechanical Engineering

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

Preferred

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

1+ Years Experience working independently or as a team member in a fast-paced environment with rapidly changing priorities

Benefits

Receive a competitive salary and benefits package as you grow your career at DiaSorin.

Company

Diasorin

Glassdoor3.1

DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics

Founded in 1968

Saluggia, Piemonte, ITA

1001-5000 employees

https://www.diasorin.com/

H1B Sponsorship

Diasorin has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (1)

2022 (1)