Manufacturing Engineer - Level II

Diasorin•Austin, TX

36d

About The Position

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.

Requirements

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 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

Nice To Haves

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)

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.