- Bayan Lepas Pulau Pinang Malaysia
Jabil Hiring! Full Time NPI Product Engineer in Pulau Pinang - Ricebowl
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Job Description – NPI Engineer (Medical Workcell)
Position Title:NPI Engineer (Medical Workcell)
Location:Jabil Penang, Malaysia
Department: NPI Engineering
Job Summary
The NPI Engineer is responsible for leading the introduction of new medical products from prototype through production ramp-up while ensuring compliance with customer requirements, quality standards, regulatory requirements, and manufacturing readiness. The role serves as the primary engineering interface between customers, operations, quality, manufacturing, and suppliers to ensure successful product launches and sustainable production performance.
Key Responsibilities
New Product Introduction (NPI)
* Lead product transfer activities from customer design phase through mass production.
* Coordinate cross-functional teams to ensure smooth execution of NPI projects.
* Develop and manage project timelines, deliverables, and milestone tracking.
* Review product design for manufacturability (DFM), assembly (DFA).
* Drive risk assessments and mitigation plans during product introduction.
Manufacturing Process Development
* Develop, validate, and optimize manufacturing processes for PCBA and system assembly.
* Define process flow, work instructions, tooling, fixtures, and equipment requirements.
* Conduct process characterization, DOE, and capability studies.
* Support process validation activities including IQ, OQ, and PQ where applicable.
* Ensure manufacturing processes comply with medical device quality requirements.
Quality & Regulatory Compliance
* Ensure compliance with ISO 13485, FDA QSR, GMP, and customer-specific requirements.
* Support PFMEA, Control Plan, Process Validation, and Risk Management activities.
* Participate in internal, customer, and regulatory audits.
* Drive CAPA activities related to manufacturing and process issues.
* Support product and process change management through ECO/ECN implementation.
Production Support
* Provide engineering support during pilot runs and production ramp-up.
* Investigate manufacturing issues using structured problem-solving methodologies (8D, 5 Why, Fishbone, DMAIC).
* Drive yield improvement, defect reduction, and productivity enhancement initiatives.
* Monitor KPIs including yield, OEE, cycle time, scrap, and customer quality metrics.
Customer & Supplier Management
* Act as technical focal point for customer engineering discussions.
* Coordinate qualification of new materials, equipment, and suppliers.
* Review and approve engineering documentation and manufacturing specifications.
* Support customer visits, audits, and business reviews.
Required Qualifications
* Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Electronic Engineering, Mechatronics Engineering, or related field.
* Minimum 3–5 years of experience in NPI, Manufacturing Engineering, Process Engineering, or related field.
* Experience in medical device manufacturing environment is preferred.
* Knowledge of SMT, PCBA, system assembly, soldering, testing, and manufacturing processes.
* Familiarity with validation methodologies (IQ/OQ/PQ).
* Strong understanding of quality tools including PFMEA, Control Plan, MSA, SPC, and DOE.
* Knowledge of ISO 13485, FDA regulations, and GMP requirements is an advantage.
Technical Skills
* Project management and cross-functional coordination.
* Root cause analysis and problem-solving methodologies.
* Statistical analysis and process capability studies.
* Manufacturing process development and validation.
* Documentation control and change management.
* Proficiency in Microsoft Office, Minitab, and MES systems.
Soft Skills
* Strong communication and presentation skills.
* Ability to lead cross-functional teams.
* Effective stakeholder management.
* Strong analytical and decision-making capabilities.
* Ability to work under pressure and manage multiple projects simultaneously.
Key Performance Indicators (KPI)
* NPI project milestone adherence.
* Production readiness on schedule.
* First-pass yield during pilot and ramp-up.
* Manufacturing cost and cycle time improvements.
* Customer satisfaction and audit performance.
* Reduction of process-related defects and escapes.
* Successful completion of validation and qualification activities.
### Preferred Experience
* Medical device manufacturing.
* SMT, Reflow, Wave Soldering, Selective Soldering, Laser Soldering, and Underfill processes.
* Product transfer between sites.
* Automation and Industry 4.0 initiatives.
* High-mix, low-volume manufacturing environment.
This role is ideal for engineers who enjoy project leadership, problem solving, manufacturing process development, and working closely with customers to bring life-saving medical products from concept to production.
Position Title:NPI Engineer (Medical Workcell)
Location:Jabil Penang, Malaysia
Department: NPI Engineering
Job Summary
The NPI Engineer is responsible for leading the introduction of new medical products from prototype through production ramp-up while ensuring compliance with customer requirements, quality standards, regulatory requirements, and manufacturing readiness. The role serves as the primary engineering interface between customers, operations, quality, manufacturing, and suppliers to ensure successful product launches and sustainable production performance.
Key Responsibilities
New Product Introduction (NPI)
* Lead product transfer activities from customer design phase through mass production.
* Coordinate cross-functional teams to ensure smooth execution of NPI projects.
* Develop and manage project timelines, deliverables, and milestone tracking.
* Review product design for manufacturability (DFM), assembly (DFA).
* Drive risk assessments and mitigation plans during product introduction.
Manufacturing Process Development
* Develop, validate, and optimize manufacturing processes for PCBA and system assembly.
* Define process flow, work instructions, tooling, fixtures, and equipment requirements.
* Conduct process characterization, DOE, and capability studies.
* Support process validation activities including IQ, OQ, and PQ where applicable.
* Ensure manufacturing processes comply with medical device quality requirements.
Quality & Regulatory Compliance
* Ensure compliance with ISO 13485, FDA QSR, GMP, and customer-specific requirements.
* Support PFMEA, Control Plan, Process Validation, and Risk Management activities.
* Participate in internal, customer, and regulatory audits.
* Drive CAPA activities related to manufacturing and process issues.
* Support product and process change management through ECO/ECN implementation.
Production Support
* Provide engineering support during pilot runs and production ramp-up.
* Investigate manufacturing issues using structured problem-solving methodologies (8D, 5 Why, Fishbone, DMAIC).
* Drive yield improvement, defect reduction, and productivity enhancement initiatives.
* Monitor KPIs including yield, OEE, cycle time, scrap, and customer quality metrics.
Customer & Supplier Management
* Act as technical focal point for customer engineering discussions.
* Coordinate qualification of new materials, equipment, and suppliers.
* Review and approve engineering documentation and manufacturing specifications.
* Support customer visits, audits, and business reviews.
Required Qualifications
* Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Electronic Engineering, Mechatronics Engineering, or related field.
* Minimum 3–5 years of experience in NPI, Manufacturing Engineering, Process Engineering, or related field.
* Experience in medical device manufacturing environment is preferred.
* Knowledge of SMT, PCBA, system assembly, soldering, testing, and manufacturing processes.
* Familiarity with validation methodologies (IQ/OQ/PQ).
* Strong understanding of quality tools including PFMEA, Control Plan, MSA, SPC, and DOE.
* Knowledge of ISO 13485, FDA regulations, and GMP requirements is an advantage.
Technical Skills
* Project management and cross-functional coordination.
* Root cause analysis and problem-solving methodologies.
* Statistical analysis and process capability studies.
* Manufacturing process development and validation.
* Documentation control and change management.
* Proficiency in Microsoft Office, Minitab, and MES systems.
Soft Skills
* Strong communication and presentation skills.
* Ability to lead cross-functional teams.
* Effective stakeholder management.
* Strong analytical and decision-making capabilities.
* Ability to work under pressure and manage multiple projects simultaneously.
Key Performance Indicators (KPI)
* NPI project milestone adherence.
* Production readiness on schedule.
* First-pass yield during pilot and ramp-up.
* Manufacturing cost and cycle time improvements.
* Customer satisfaction and audit performance.
* Reduction of process-related defects and escapes.
* Successful completion of validation and qualification activities.
### Preferred Experience
* Medical device manufacturing.
* SMT, Reflow, Wave Soldering, Selective Soldering, Laser Soldering, and Underfill processes.
* Product transfer between sites.
* Automation and Industry 4.0 initiatives.
* High-mix, low-volume manufacturing environment.
This role is ideal for engineers who enjoy project leadership, problem solving, manufacturing process development, and working closely with customers to bring life-saving medical products from concept to production.
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