New Product Implementation (NPI) / Process Engineer

PT. Beurer Indonesia Technology; Kendal; On-site; IDR 200,880,000 - 357,120,000; Full time

Job summary

PT. Beurer Indonesia Technology is seeking a New Product Implementation (NPI) / Process Engineer to lead the link between head office product development and local production in Kendal.

You will manage NPI timelines, define processes, run trials, validate documentation, and drive improvements while ensuring compliance with ISO 9001 and ISO 13485.

Qualifications

• University degree in electronics, mechanical or any engineering field.
• 3-5 years in development or production of electronic medical products.
• Ability to review and develop SOP and WI for new product.
• Experience creating BOM for product.
• Well organized with project work experience and able to meet tight deadlines.
• Experience in an international industry is a plus.

Responsibilities

• Act as main contact with head office/product development for NPI.
• Receive information for new products and specifications for Production and QC.
• Review product specs, BOM, drawings, and manufacturing requirements.
• Define process flow, work instructions, equipment, and production parameters.
• Conduct process trials, pilot runs, and line readiness with Production and QC.
• Optimize processes for productivity and cost efficiency.
• Prepare validation documentation (IQ/OQ/PQ).
• Develop PFMEA, Controls, Process Specifications with Quality and Production.
• Investigate defects and implement corrective actions.
• Identify and implement process improvement projects.
• Improve line efficiency, cycle time, and production capacity.
• Train production personnel on new processes and monitor effectiveness.
• Coordinate engineering changes and assess impact on process/equipment/documentation.

Skills

Microsoft Office

ISO 9001

ISO 13485

Analytical thinking

English communication

Project management

Process Validation

Documentation

Education

University degree in electronics or mechanical engineering

Job description

New Product Implementation (NPI) / Process Engineer

· As the person in charge or main contact with the head office/product development department related to the new product or changing the design and document

· Receive information for new products and product specifications such as technical specification, drawing, BOM, SOP for Production and QC process

· Review product specification, BOM, Drawings, and Manufacturing Requirements

· Prepare and monitor NPI Project Timelines, milestones, and deliverables

· Define process flow, work instruction, equipment, tools, and production parameters

· Conduct process trial, pilot run, and line readiness assessment together with Production and QC

· Optimize process for productivity and cost efficiency

· Prepare process validation documentation, including IQ/OQ/PQ

· Develop PFMEA, Control, Process Specification with Quality and Production

· Investigate process-related defects and implement corrective action

· Identify and implement process improvement project

· Improve line efficiency, cycle time, and production capacity

· Standardize successful improvement and monitor their effectiveness

· Train production personnel on new process and work instruction

· Coordinate engineering changes and assess their impact on process, equipment, and documentation.

Qualifications:

· University degree in electronic, mechanic and any engineering field

· Having 3-5 years of experience in the development or production of electronic medical products will be advantage

· Ability to review and develop SOP and WI for new product

· Knowledge/experience to create of BOM for product

· Well organized, with proven project work experience and the ability to work with very tight deadlines to complete project designs and changes. Predictively estimate the project risk before the design starts and arrange appropriate treatment measures

· Have experienced job with an international industry will be an advantage

Skills:

· Proficiency with Microsoft Office

· Having knowledge of ISO 9001 & ISO 13485

· Validation Documentation & Traceability

· Have good analytical thinking

· Good written and spoken in English