Manufacturing Engineer - Level II

About the role

The Manufacturing Engineer, Level II plays a crucial role in enhancing the efficiency and reliability of Instruments Manufacturing operations at Diasorin. This position involves designing, developing, and implementing control systems, troubleshooting issues, and ensuring compliance with regulatory standards.

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.

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.
• 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 requirements 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)

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.
• 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

Diasorin offers a competitive salary and benefits package to support your professional growth and well-being. Our commitment to diversity, equity, and inclusion ensures that everyone feels valued and empowered to contribute to our mission of improving patient outcomes worldwide.

Pay

Competitive compensation package tailored to individual qualifications and experience.

Schedule

Flexible schedule to accommodate your needs and the demands of the role.