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Manufacturing Engineer - Level I

Job in Austin, Travis County, Texas, 78716, USA
Listing for: DiaSorin
Full Time position
Listed on 2026-01-14
Job specializations:
  • Engineering
    Quality Engineering, Manufacturing Engineer
Job Description & How to Apply Below

Diasorin Overview

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Dia Sorin?
  • Impactful Work:
    When you join Dia Sorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
  • Global Reach & Innovation:
    Our work transcends borders. Joining Dia Sorin means collaborating with colleagues from all over the horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
  • Diverse and Inclusive Culture:
    We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.
Join Our Team

If you're passionate about innovation, diversity, and making a positive impact on healthcare, Dia Sorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics?

Join Dia Sorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

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…
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