Manufacturing Engineer The manufacturing engineer for the assembly process is responsible for designing, scaling, and optimizing assembly operations for electromechanical medical device assemblies to ensure consistent, high-quality production. Designs assembly processes, tooling, and line layouts while establishing robust controls aligned with PFMEA and GMP requirements in a low volume / high mix environment. Serves as a technical liaison for customer design transfers, supports validation activities, and drives continuous improvement initiatives to enhance efficiency and reduce costs. Provides mentoring and training to production personnel, and acts as a subject matter expert in troubleshooting, CAPA, and GMP process compliance.
Essential Duties and Responsibilities:
Define and optimize assembly processes and line layouts for medical device electromechanical assemblies. Develop and maintain work instructions, process flows, handling and maintenance requirements, quality checklists and drawings, while identifying opportunities to improve efficiency, throughput and overall process capability. Establish and maintain PFMEA-aligned assembly process controls to support successful product launches and design transfers. Define ERP BOM structures and develop assembly documentation in compliance with GMP requirements. Support and participate in design prototype builds and full-line process validation activities, including IQ/OQ/PQ as required. Drive process development and scale-up efforts, including the design, procurement and fabrication of tools, fixtures, gauges, and equipment to enable controlled, repeatable manufacturing of electromechanical assemblies. Serve as a technical lead when interfacing with customers, supporting manufacturing transfer activities and implementation of customer-specific requirements. Train and mentor assembly personnel and quality teams on defined processes. Execute tasks across multiple projects simultaneously, providing regular updates, adapting to shifting priorities, and collaborating cross-functionally to ensure on-time delivery while maintaining balanced workloads. Serve as a subject matter expert (SME) in CAPA and deviation investigations for manufacturing processes. Identify and address process gaps using structured problem-solving methodologies, including root cause analysis, error-proofing techniques, and the implementation of sustainable corrective actions. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.
Education:
Bachelor's degree in mechanical, Biomedical, Manufacturing, Industrial Engineering, or a related technical field; or an associate's degree in a technical discipline combined with relevant experience. Experience and/or Training: Minimum of 2 years of experience, or an equivalent combination of education and relevant manufacturing experience, in a production environment focused on mechanical and electrical assemblies. Includes hands-on experience in fixture and tooling design, manufacturing process development, and full product builds, as well as assembly line operations and electro-mechanical systems (medical device industry experience preferred).Proficient in power tools, hand tools, precision measurement instruments, and electrical testing equipment. Proficient in interpreting and creating engineering drawings, technical documentation, and specifications. Proficient with SolidWorks, ProE, AutoCAD, or other CAD software. Experience using root cause and problem-solving methodologies (DMAIC, 5 Whys, Fishbone, etc.).Working knowledge of ISO 9001 & 13485 Quality System requirements. Knowledge of FDA regulations is preferred. Experience supporting continuous improvement initiatives. Six Sigma Green Belt or Black Belt certification (preferred).Proficiency in Microsoft Office Suite. Physical and Mental Demands: Frequent prolonged standing and sitting standing and walking in office, manufacturing, warehouse, or operational environments. Occasional bending, reaching, climbing stairs, and light lifting (up to 40 lbs., if applicable).Visual acuity to review data, analyze reports, and observe operational processes, with color perception required. High level of analytical thinking and problem-solving to evaluate complex processes and identify root causes. Ability to interpret data, metrics, and financial impact analyses to drive decisions. Ability to manage multiple projects simultaneously with shifting priorities. High attention to detail with strong organizational skills. Effective communication skills, including presenting to customers and frontline teams. Resilience and adaptability in dynamic operational settings. Ability to receive and provide instructions in a positive manner. Flexible to change and possess a high degree level of integrity and "can do attitude".
