Manufacturing Engineer - Level II

Job Scope

The Manufacturing Engineer, Level II will design, develop, and implement automated control systems to enhance the efficiency and reliability of 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).

• Facilitate the definition of project tasks, establish timelines, and fulfill responsibilities for product design transfer and related process engineering.
• Facilitate the investigation and resolution of findings identified through audits, non-conformances, corrective/preventative actions, or customer complaints.
• Provide task-specific and change control training of Manufacturing personnel.

Job Duties and 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.

Education, Experience and 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.
• 3-5 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.

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.

Preferred Skills

• 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).

Travel Requirements

10% Travel may be required up to 10% of the time.