Manufacturing Engineer - Level II

DiaSorin • Austin, TX

22h

About The Position

The Manufacturing Engineer, Level II designs, develops, and implements automated control systems to improve the efficiency and reliability of Instruments Manufacturing operations in an ISO 13485- and FDA-regulated medical-device environment. The role facilitates project task definition and timeline development, supports product design transfer and process engineering, and helps investigate and resolve audit findings, non-conformances, corrective and preventive actions, and customer complaints. It also provides task-specific and change-control training to Manufacturing personnel.

The engineer owns the design, specification, and selection of new production equipment—including test fixtures, manufacturing aids, and automation equipment—and supports process scale-up and development. The role works with R&D, Quality Assurance, Manufacturing, and external partners on automation solutions, engineering and document change controls, infrastructure improvements, technology transfers, and contract manufacturing transfers. It maintains regulatory and safety compliance, including applicable FDA, ISO 13485, NFPA, OSHA, and lockout requirements.

Requirements

• Bachelor’s degree in a relevant engineering discipline; electrical, automation, or process control is preferred. The posting also lists Electrical Engineering, Mechanical Engineering, Automation Engineering, or a related field.
• 3–5 years of experience in control or automation engineering, preferably in medical devices or a similar regulated industry.
• Proficiency in programming and configuring HMI systems.
• Data analytics experience with SQL, Tableau, or Power BI.
• Experience programming in Python for scripting and automation.
• Advanced user of SolidWorks.
• Experience with SCADA systems and industrial networks.
• Equipment integration experience using IIoT, OPC, and/or PTC Kepware.
• Ability to debug electrical, mechanical, and microfluidics 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 defined by FDA Quality System guidelines.
• Demonstrated results applying Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments.
• Aptitude in mathematics, statistics, data analysis, and technical writing.
• Excellent oral and written communication, problem-solving, teamwork, and attention-to-detail skills.
• Knowledge of Geometric Dimensioning & Tolerancing and exposure to CAD/design/engineering.
• PLC programming skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Strong organization, time-management, and prioritization skills.
• Ability to work independently with minimal supervision and meet 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 a related field, such as ASQ or Six Sigma.

Responsibilities

• Design, develop, and implement automation control systems for medical-device manufacturing.
• 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 control systems to maintain performance and reliability.
• Ensure control-system design and implementation comply with applicable FDA and ISO 13485 requirements.
• Develop and maintain control-system documentation, including schematics, wiring diagrams, and software code.
• Conduct risk assessments and participate in FMEA to identify and mitigate potential issues.
• Own the design, specification development, and selection of production equipment, including test fixtures, manufacturing aids, and automation equipment; support process scale-up and new process development.
• Monitor industry trends, standards, and technological advancements to improve automation processes.
• Lead and assist engineering and document change-control activities, including participation in change-control reviews.
• Ensure Manufacturing and Quality Control personnel are trained on transferred test fixtures, manufacturing aids, and automation equipment.
• Assist in investigating and resolving findings from audits, non-conformances, corrective and preventive actions, and customer complaint escalations.
• Lead and assist with design input and implementation oversight for infrastructure improvement projects.
• Lead and assist external technology transfers and contract manufacturing transfers.
• Comply with and promote the Quality System and other applicable regulations.
• Ensure compliance with NFPA, OSHA, lockout, and other applicable safety standards.
• Perform other duties as assigned.

Benefits

• Competitive rewards package focused on overall well-being.
• Health benefits.
• Retirement and financial-wellbeing programs.
• Time-off programs.
• Wellbeing support and perks.
• Possible eligibility to participate in an annual incentive program; any award depends on individual and organizational performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level