Manufacturing Engineer III (Medical Device | Capital Equipment)

General Summary

The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and support continuous improvement in production. Area of work involves manufacturing processes with interaction between production and cross-departmental engineering groups in resolving problems encountered on the production floor and across the business.

Specific Duties and Responsibilities

• Support capital equipment manufactured through contract manufacturers (CMs), including working directly with suppliers on manufacturing, quality, and technical issues.
• Demonstrate hands-on experience navigating and executing within a QMS environment, including NCRs/nonconformances, CAPAs, deviations, change controls, supplier corrective actions, and design/manufacturing documentation.
• Design, execute, and document test plans for qualification of PCBA components.
• Evaluate and qualify alternate electronic components for PCBAs by comparing electrical, mechanical, functional, reliability, and lifecycle specifications against existing components to ensure form, fit, function, and performance equivalency.
• Engage in the troubleshooting of electromechanical products by employing failure analysis and problem-solving techniques, while also recommending and implementing effective solutions.
• Execute detailed root cause analysis and recommend vetted solutions.
• Communicate and explain problems and solutions cross-functionally and inter-departmentally.
• Collaborate closely with suppliers, ensure timely communication of updates, and respectfully request any necessary changes.
• Manage NCRs, deviations, engineering change orders, and supplier documentation while utilizing a Quality Management System to ensure continuous improvement and compliance.
• Lead the implementation of projects at the supplier level, managing communications related to test plans, monitoring project timelines, and ensuring all milestones are met efficiently.
• Solve complex problems and implement innovative solutions.
• Approach problems from a detail-oriented perspective.
• Support production; create and maintain product and process documentation; monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield, efficiency, and/or throughput.
• Test processes, equipment, raw materials, and product. Perform process validations. Author protocols to execute tests, write reports, and make conclusions and/or recommendations based on test results.
• Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project.
• Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience.
• Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans.
• Participate in project planning and scheduling.
• Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation.
• Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.

Position Qualifications

Minimum education and experience: Bachelor's degree in Electrical, Biomedical, Mechanical, Chemical, Materials, or Industrial Engineering or related degree with 4+ years relevant engineering experience, or an equivalent combination of education and experience.

• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Excellent written, verbal, and interpersonal communication skills required; leadership skills desired
• Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired
• Proficiency in Word, Excel, PowerPoint, Access, and other computer applications required

Working Conditions

• General office, laboratory, and clean room environments.
• Willingness and ability to work on site.
• Business travel from 0% - 10%.
• Potential exposure to blood-borne pathogens.
• Requires some lifting and moving of up to 25 pounds.