Manufacturing Engineer - Level II

DiaSorin; Austin (TX); On-site; USD 85,000 - 115,000; Full time

Job summary

Diasorin is seeking a Manufacturing Engineer, Level II, to design, develop, and implement automated control systems for Instruments Manufacturing in a regulated environment (ISO 13485 and FDA). You will collaborate with R&D, QA, and Manufacturing to identify needs and drive solutions, while ensuring thorough documentation and adherence to quality systems.

The role requires 3–5 years of control/automation engineering experience, PLC/HMI programming skills, and proficiency with data analytics

Qualifications

• Bachelor’s degree in Electrical Engineering, Automation Engineering, or related field.
• 3-5 years experience in control/automation engineering in regulated environment (medical device preferred).
• Proficiency in programming and configuring HMI systems.
• Data analytics experience (SQL, Tableau, Power BI).
• Experience with SCADA systems and industrial networks.
• Proficiency in SolidWorks.

Responsibilities

• Design, develop, and implement control systems for automation in the manufacturing of medical devices.
• Develop and program PLCs and/or HMI 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 reliability.
• Ensure compliance with regulatory standards (FDA, ISO 13485) in design and implementation.
• Lead engineering change control and document change control activities.
• Train Manufacturing and Quality Control personnel for transfer of new test fixtures, manufacturing aids, and automation equipment.

Skills

PLC programming

HMI systems

Data analytics

Python scripting

SolidWorks

SCADA systems

Industrial networks

OPC Kepware

Education

Electrical Engineering

Automation Engineering

Tools

SolidWorks

SQL

Tableau

Power BI

OPC Kepware

IIoT

Job description

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

Why Join Diasorin

• Build What Matters Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People-Centered Culture Thrive in a culture that values accountability, inclusion, and continuous development.

Job Scope

The Manufacturing Engineer, Level II will be responsible for: designing, developing, and implementing automated control systems to enhance the efficiency and reliability of our Instruments Manufacturing operations. This role requires a strong technical background, attention to detail, and a deep understanding of automation and control systems in a regulated environment (ISO 13485 and FDA regulated medical device setting). Facilitating in the definition of project tasks, establishing timelines, and fulfilling responsibilities for product design transfer and related process engineering. 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.

Job Duties And Responsibilties

• 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.

Education, Experience And Qualifications

• 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.

Training And Skills

• 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 Skills:

• 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)

Travel Requirements

• 10% Travel may be required up to 10% of the time

What We Offer

Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

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, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact [e-mail].