Manufacturing Engineer - Level II

• 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

• 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

• 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)

competitive salary and benefits package