Diasorin · 12 hours ago
Manufacturing Engineer - Level II
Austin, TX
Full-time
Onsite
Mid Level
3+ years expDiasorin is a global leader in diagnostic solutions, dedicated to improving healthcare worldwide. The Manufacturing Engineer, Level II will design, develop, and implement automated control systems to enhance the efficiency and reliability of manufacturing operations in a regulated environment.
BiotechnologyHealth Diagnostics
Responsibilities
Design, develop, and implement control systems for automation in the manufacturing of medical devices
Develop and program PLCs (Programmable Logic Controllers) and/or HMI (Human-Machine Interface) systems
Collaborate with R&D, Quality Assurance, and Manufacturing teams to identify automation needs and develop solutions
Troubleshoot and resolve control system issues to ensure optimal performance and reliability
Ensure compliance with regulatory standards (e.g., FDA, ISO 13485) in the design and implementation of control systems
Develop and maintain detailed documentation of control systems, including schematics, wiring diagrams, and software code
Conduct risk assessments and participate in Failure Modes and Effects Analysis (FMEA) to identify and mitigate potential issues
Assume full ownership of 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
Stay updated on industry trends, standards, and technological advancements to continuously improve automation processes
Lead and assist in engineering change control and document change control activities; participate in change control reviews
Ensure effective training of Manufacturing and Quality Control personnel for transfer of new test fixtures, manufacturing aids, and automation equipment
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
Lead and assist external technology transfers and contract manufacturing transfers
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
Other duties as assigned
Qualification
Required
Bachelor's degree in relevant engineering discipline; electrical, automation, or process control preferred
Bachelor's degree in Electrical Engineering, Mechanical Engineering, Automation Engineering, or a related field
3-5 years of experience in control/automation engineering, preferably in the medical device or a similar regulated industry
Proficiency in programming and configuring HMI systems
Data analytics experience (SQL, Tableau, Power BI)
Experience programming in Python (Scripting and Automation)
Advanced user of SolidWorks
Excellent problem-solving skills and attention to detail
Strong communication and teamwork skills
Experience with SCADA systems and industrial networks
Equipment integration experience using IIoT, OPC and/or PTC Kepware
Ability to debug electrical, mechanical & micro fluidics components
Expertise in developing requirement for sensors and actuators
Thorough knowledge of ISO 13485 and FDA Quality System requirements
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
Geometric Dimensioning & Tolerancing
CAD/design/engineering exposure
PLC programming
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
Familiarity with LabVIEW, MATLAB, or other automation software
Experience with robotics and motion control systems
Certification in Quality Assurance or related fields (e.g., ASQ, Six Sigma)
Benefits
Receive a competitive salary and benefits package as you grow your career at Diasorin.
Company
Diasorin
DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics
1001-5000 employees
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)
Funding
Current Stage
Late StageLeadership Team
Piergiorgio Pedron
CFO - Group Supply Chain & Procurement
Recent News
2026-02-04
2026-01-23
Company data provided by crunchbase