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About the Role

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.

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.

Requirements

• 2+ 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.
• 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).

Skills

• Automation
• Control Systems
• ISO 13485
• FDA Regulations
• PLC Programming
• HMI Systems
• R&D Collaboration
• Quality Assurance
• Manufacturing Operations
• Troubleshooting
• Documentation
• Risk Assessment
• FMEA
• Design Control
• Six Sigma
• Lean Manufacturing
• Statistical Design of Experiments
• Data Analytics
• Python Scripting
• SolidWorks
• SCADA Systems
• Industrial Networks
• IIoT
• OPC
• PTC Kepware
• Robotics
• Motion Control
• LabVIEW
• MATLAB
• Quality Assurance Certification
• ASQ
• Microsoft Office Suite

Location

• Remote
• Hybrid
• Onsite

Work Type

• Full-time
• Contract

Experience Level

• Level II
• 2+ years

Education Level

• Bachelor's degree in Electrical Engineering
• Bachelor's degree in Mechanical Engineering
• Bachelor's degree in Automation Engineering
• Bachelor's degree in a related field

Benefits

• Competitive salary
• Benefits package

About the Company

• Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide.
• For more than 50 years, Diasorin has combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.
• Diasorin continuously invests in research, technology, and people.
• Guided by our values of operational excellence, customer focus, and teamwork, Diasorin empowers 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.
• Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers.
• Diasorin believes diverse perspectives strengthen innovation and help deliver meaningful impact for patients and customers worldwide.

Equal Opportunity

• 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.