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Diasorin · 1 day ago

Manufacturing Engineer II

Austin, TX

Full-time

Onsite

Mid Level

3+ years exp

Diasorin is a global leader in diagnostic solutions, dedicated to improving healthcare worldwide. The Manufacturing Engineer II will provide technical support for manufacturing operations, lead engineering initiatives, and collaborate with cross-functional teams to enhance product quality and efficiency in a regulated environment.

BiotechnologyHealth Diagnostics

H1B Sponsor Likely

Responsibilities

Represent Operations in cross-functional design teams to deliver transfer of design changes or new product introduction of instruments and consumables through 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

Participate in the design, specification development and selection of new production equipment, such as, test fixtures, manufacturing aids, and automation equipment; includes scale-up of existing processes and development of new processes

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; interface with Cost Accounting for new or on-market product COGs roll-up

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

Lead and assist in design input and implementation oversight of infrastructure improvement projects

Provide packaging and labeling design support

Participate in cross-functional teams supporting business process improvement and alignment initiatives

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

Qualification

ISO 13485 knowledgeFDA Quality System knowledgeProcess improvement experienceSix Sigma principlesProduct Lifecycle ManagementDesign Control requirementsSCADA systems experienceMicrosoft Office proficiencyTechnical writing aptitudeCommunication skillsTeamwork skillsTime management skillsProblem-solving skills

Required

Bachelor's degree in Mechanical, Electrical, Industrial, Bio-medical, or Biomechanical Engineering

3-5 years of experience in process improvement and sustaining engineering in a ISO 13485 and/or FDA regulated Life Sciences, Medical Device, or Medical Technology industry

Thorough knowledge of ISO 13485 and FDA Quality System requirements

Proficiency in the use of Product Lifecycle Management, including applied knowledge of Engineering Change Control

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

Excellent problem-solving skills and attention to detail

Strong communication and teamwork skills

Experience with SCADA systems and industrial networks

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

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

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

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2022 (1)