Manufacturing Engineer

NEXTKIDNEY SG PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

A leading medical technology company is seeking a Manufacturing Engineer to join their team in Singapore. The role involves overseeing NPI activities for mass production, managing validation protocols, and ensuring compliance with medical device regulations. Candidates should have a degree in Biomedical or Mechanical Engineering and a strong background in process validation.

Qualifications

• More than 3 years experience of process validation in the medical device industry.
• Knowledge of GMP, ISO 13485 protocols, and FDA standards.
• Strong proficiency in statistical analysis and effective communication.

Responsibilities

• Develop and implement methodology for new processes for medical devices.
• Manage contract manufacturers and ensure on-time delivery.
• Prepare manufacturing documents in accordance with ISO 13485 requirements.

Skills

Process validation

Statistical analysis

Risk assessment

Technical writing

Education

Bachelor's Degree in Biomedical or Mechanical Engineering

Tools

SAP

Job description

About Us

Nextkidney is a leading medical technology company in the development of sorbent based portable hemodialysis device. Headquarters in Netherlands, the group comprises of a subsidiary in Lausanne, Switzerland and in Singapore. In Singapore, we are focused on the developing the dialysate regenerative system for use with the portable hemodialysis device. Our vision is to be the global leader in making portable dialysis affordable and accessible to all. Learn more about us at www.nextkidney.com

Nextkidney SG is seeking dedicated and talented individuals with a proactive and positive ‘can-do’ attitude to join our team. We are looking to add a Manufacturing Engineer in Singapore. As a Manufacturing Engineer, you will be responsible to carry out NPI activities for successful product transfer into mass production, providing engineering support to sustain manufacturing in mass production.

Responsibilities

• Develop and implement a methodology for the implementation of new and improved processes, and validation plans for medical devices.
• Manage and develop validation protocols (IQ/OQ, PQ), execute validation tests and document results accurately.
• Management of contract manufacturer and suppliers to ensure on time delivery and quality.
• Responsible for the production line setup and equipment planning, define manufacturing line layout, sourcing for tooling, fixtures and equipment and CAPEX.
• Responsible for ramp-up, maintenance and improvement of manufacturing systems by identifying and implementing areas for improvement.
• Apply Lean manufacturing concept to minimise waste of material and labour. Proactively lead and participate in cost reduction, yield improvement activities.
• Prepare and release manufacturing related documents in accordance with ISO 13485 requirements.
• Lead the implementation of engineering changes into production.
• Determines root cause and corrective action analysis for issues that arise during assembly and/or test of systems; provides failure analysis report and/or corrective/continuous improvement actions as required.
• Performs Process Failure Mode, Effects and Criticality Analysis when working with New Product Development.
• Conduct proof of concept for new technologies and comply with ISO13485, GMP and FDA regulations.
• Facilitate and participate in quality, productivity and cost reduction improvement.
• Calculating production, labour, material costs; review production schedules; estimating future requirements.
• Responsible for Health & Safety include accident investigation and corrective action.
• Stay updated with emerging trends, technologies, and medical device production regulations.
• Collaborates with cross-functional teams, including Engineering, Manufacturing, Quality Assurance and Others.

Requirements

• Bachelor's Degree in Biomedical or Mechanical Engineering or relevant field.
• More than 3 years experience of process validation, preferably in the medical device industry.
• Knowledge of Medical or Life Science Instrument Manufacturing and exposure to GMP ISO 13485, protocols for validations and qualifications including IQ/OQ/PQ.
• Strong understanding of FDA, GMP and ISO 13485 standards; proficiency in statistical analysis and risk assessment methodologies; excellent knowledge of SAP and excellent technical writing skills

Attributes:

• Able to work independently
• Effective communicator
• Eye for detail

Be part of the Nextkidney family!

Please reply with your resume and expected salary