- Bayan Lepas, Penang Bayan Lepas Pulau Pinang Malaysia
Working Location
Job Description
Responsibilities
Jabil is a global manufacturing powerhouse with over 140,000 employees across 100 locations in 25+ countries. While we may not be a household name, we're the force behind products from 300 of the world's biggest brands across healthcare, packaging, smartphones, automotive, and home appliances industries.
At Jabil, we aim to make ANYTHING POSSIBLE and EVERYTHING BETTER. We leverage extensive market experience, technical and design capabilities, manufacturing expertise, and global supply chain insights to drive success for leading brands while creating a positive impact for our people, communities, and the environment. Join us to be part of manufacturing innovation that touches lives worldwide.
Role OverviewThe 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.
What You'll DoNew Product Introduction (NPI)
Lead product transfer activities from customer design phase through mass production, coordinating cross-functional teams to ensure smooth NPI project execution
Develop and manage project timelines, deliverables, and milestone tracking while driving risk assessments and mitigation plans during product introduction phases
Review product designs for manufacturability (DFM) and assembly (DFA), providing feedback to customers to optimize designs for production efficiency and quality
Manufacturing Process Development
Develop, validate, and optimize manufacturing processes for PCBA and system assembly including SMT, reflow, wave soldering, selective soldering, laser soldering, and underfill processes
Define process flow, work instructions, tooling, fixtures, and equipment requirements while conducting process characterization, DOE, and capability studies
Support process validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for medical device compliance
Quality & Regulatory Compliance
Ensure compliance with ISO 13485, FDA QSR (Quality System Regulation), GMP (Good Manufacturing Practice), and customer-specific quality requirements
Support PFMEA (Process Failure Mode and Effects Analysis), Control Plan development, Process Validation, and Risk Management activities
Participate in internal, customer, and regulatory audits while driving CAPA (Corrective and Preventive Action) activities related to manufacturing and process issues
Support product and process change management through Engineering Change Order (ECO) and Engineering Change Notice (ECN) implementation
Production Support & Continuous Improvement
Provide engineering support during pilot runs and production ramp-up, investigating manufacturing issues using structured problem-solving methodologies (8D, 5 Why, Fishbone, DMAIC)
Drive yield improvement, defect reduction, and productivity enhancement initiatives while monitoring KPIs including yield, OEE, cycle time, scrap, and customer quality metrics
Act as technical focal point for customer engineering discussions, coordinate qualification of new materials and equipment, and support customer visits, audits, and business reviews
Must Have:
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 with proven track record of successful product launches
Knowledge of SMT, PCBA, system assembly, soldering processes, testing methodologies, and manufacturing operations
Strong understanding of quality tools including PFMEA, Control Plan, MSA (Measurement System Analysis), SPC (Statistical Process Control), and DOE (Design of Experiments)
Familiarity with validation methodologies (IQ/OQ/PQ) and structured problem-solving approaches
Project management skills with ability to lead cross-functional teams and manage multiple projects simultaneously
Proficiency in Microsoft Office, Minitab (or statistical analysis software), and MES (Manufacturing Execution Systems)
Strong communication and presentation skills with effective stakeholder management abilities
Analytical and decision-making capabilities with ability to work under pressure and meet tight deadlines
Good to Have:
Experience in medical device manufacturing environment with knowledge of ISO 13485, FDA regulations, and GMP requirements
Hands-on experience with SMT, Reflow, Wave Soldering, Selective Soldering, Laser Soldering, and Underfill processes
Product transfer experience between manufacturing sites or facilities
Exposure to automation, robotics, and Industry 4.0 manufacturing initiatives
Experience in high-mix, low-volume manufacturing environments typical of medical device production
Six Sigma certification (Green Belt or Black Belt)
Knowledge of documentation control, change management, and regulatory submission processes
You'll be measured on:
NPI project milestone adherence and on-time delivery
Production readiness achievement on schedule
First-pass yield performance during pilot runs and ramp-up phases
Manufacturing cost reduction and cycle time improvements
Customer satisfaction scores and audit performance ratings
Reduction of process-related defects and quality escapes
Successful completion of validation and qualification activities
Process Engineering:
Manufacturing process development and optimization
Process characterization and capability studies
DOE (Design of Experiments) and statistical analysis
Process validation (IQ/OQ/PQ)
Equipment and tooling qualification
Quality & Compliance:
ISO 13485 and FDA QSR requirements
PFMEA and Control Plan development
Risk management and CAPA methodologies
Audit preparation and response
Change management (ECO/ECN)
Problem-Solving:
8D methodology
Root cause analysis (5 Why, Fishbone)
DMAIC (Six Sigma)
Data-driven decision making
Yield improvement strategies
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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