Manufacturing Process Engineer - Assembly

Job Summary:

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:

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

Experience and/or Training

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”.