وصف

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.

· Leads specific Manufacturing process improvement and development activities as assigned

· Designs and documents fixtures, tooling, and automation to meet manufacturing requirements.

· Participates in material selection, design reviews, and processing equipment selection.

· Perform and document process development, process characterization, process validation and process trouble shooting.

· Writing protocols and reports documenting process validation activities and results.

· May lead manufacturing process activities or projects.

· Evaluating process results versus manufacturing requirements.

· Coordinating and scheduling process activities with various required groups within organization

· Producing production work instructions and training Production personnel on new processes and procedures.

· Participates in project teams and conference calls while representing company to the customer.

· Support Manufacturing operations with equipment set-ups and troubleshooting

· Other responsibilities as assigned

· Abides by all safety and security rules set forth by the company and regulatory agencies.

· Regular attendance is required.

MINIMUM QUALIFICATIONS

• Skilled in mechanical design and Solidworks CAD

• Experience designing manufacturing fixtures, tools and equipment.

• 2 or more years' experience in manufacturing process development, validation, and troubleshooting.

• Experience designing, documenting, and conducting engineering studies and writing reports

• Experienced in statistical analysis, DOEs, and process capability statistics.

• Solid interpersonal and communication skills and ability to work in a team environment

• Strong problem solving skills and efficient management of time and resources

• Experience working in a Medical Device manufacturing environment (preferred)

· Bachelor's Degree in Engineering

· Ability to plan activities, work independently and complete work on schedule

· Trained in CAD

· Solid interpersonal and communication skills

· Ability to work in a team environment

· Strong problem-solving skills

· Efficient management of time and resources