Manufacturing Engineer - Level I

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 Diasorin?

• Impactful Work: When you join Diasorin, 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 Diasorin means collaborating with colleagues from all over the world, expanding your 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, Diasorin 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 Diasorin 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 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

• Must work onsite at Luminex office

• Constantly

• 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

• 10% 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 hrtalent@diasorin.com or 1-800-328-1482 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.

Nearest Major Market: Austin