Total 15 job vacancies by Fong's Engineering And Manufacturing Pte Ltd

· Create quality inspection plans and work instructions for incoming, In-process or outgoing parts to ensure that components and products conform to specifications.

· Define training plan, train QC supervisors, QC technicians and QC inspectors to perform dimensional/functional inspection in accordance to work instructions.

· Perform First Article Inspection for newly inducted materials and parts.

· Perform qualification validation of equipment, processes and test methods

· Ensure the compliance of equipment and tools use during inspection in accordance to Calibration and Preventive Maintenance requirements.

· Participate in Process Failure Mode Effect and Analysis team to mitigate product risk arising from manufacturing

· Perform complaint handling, investigate root cause of complaint and perform Corrective Action and Preventive Action as necessary.

· Handle non-conformances and perform disposition of rejected parts, trend yield and rejects, investigate root cause of non-conformance and perform Corrective Action and Preventive Action as necessary.

· Maintain the manufacturing environment and perform gowning as necessary when working in controlled manufacturing environment e.g. clean room.

· Initiate and/or execute engineering changes in compliance with Engineering Change Control procedures

· Participate in external and internal audit to ensure company quality system is effective

· Participate in continuous improvement programs such as 6S program, yield improvement projects etc.

· Support new production introduction as a team member representing quality

· Perform other tasks as assigned by the supervisor

· Work experience as a quality engineer in a medical device manufacturing environment

(Candidates with Diploma in Engineering. Science or equivalent can be considered for Assistant Quality Engineer position. Candidates with more experience can be considered for Senior Quality Engineer position)

· Experience with qualification validation of equipment, processes and test methods for new product introduction

Job responsibilities:

• Support all production related activities.
• Ensure compliance of clean-room and GMP protocols.
• Ensure shipment, output and quality of products are met.
• Follow work instructions and compliance of good documentation practice.
• Follow instruction and work allocation from supervisor.
• As and when assigned by supervisor

Job requirements:

• Minimum secondary education
• Minimum 1 year relevant of working experience.
• Able to communicate simple English.
• Must be able to work night shift
• Able to put in Overtime hours on weekdays/Saturday, if required.
• Willing to work in Loyang

Working hours: Monday to Friday

Daily break of 45 Minutes

Day shift : 7.15 am – 4.48 pm

Night Shift: 7.00pm - 4.48am

To refer to immediate supervisor for weekly / monthly work schedule that spells out the required working days in each week / month.

• Manage engineers & contractors to peform preventive maintenance, repair maintenance, building and ground services to achieve minimum disruptions to operations
• Manages upgrading projects to ensure projects are on schedule and within the budget, complies with regulatory and technical requirements
• Works closely with project lead on project progress
• Coordinates with plant personnel when operation is affected
• Checks and builds per specification requirement
• Responsible for environmental and safety activities
• Implements lean energy program to drive improved energy efficiency
• Any other ad-hoc tasks as and when assigned by supervisor

Education

• Minimum Diploma in either Facility Engineering or Project Management

Experience

• Minimum 3 years of relevant working experience

Skills

• Desired Knowledge (1) Compressed Air systems (2) Cleanroom system (3) Air Con systems or other plant facilities equipment maintenance & (3) Operating knowledge in a manufacturing environment

Job Description:

• Responsible in preparing, compiling and analysis of financial accounting information for the month-end/year-end closing, ensuring accurate and timely reporting.
• Lead the annual budget exercise process, including forecasts, seasonality analysis, and regular budget tracking against expenditures.
• Manage/coordinate the monthly closing of the Accounts Payable, Accounts Receivable, and Fixed Assets sub-ledgers.
• Perform monthly Profit & Loss (P&L) reviews and analyse financial performance. Assist in the preparation of forecast, budget exercise and business plans.
• Supervise team members in areas such as billing, collections, resource assets management, purchasing, payments, and cash management.
• Ensure timely submission of returns and compliance with local tax regulations, including corporate tax, GST, and withholding tax filings. Liaise with tax agents, compile information for tax filing, and respond to tax-related queries raised by tax authorities or tax agents.
• Monitor and forecast cash flow, overseeing loan payments, covenants, and banking facilities.
• Act as the primary point of contact for external auditors, providing necessary financial documentation and ensuring the audit process is completed smoothly and efficiently.
• Collaborate with other departments to establish, maintain and improve processes affecting financial and management reporting.
• Perform other tasks as assigned by the supervisor.

Requirements:

• Degree in Accountancy, ACCA, or recognized Chartered Accountant (CA) qualification.
• Minimum of 5 years of relevant experience, with a strong background in financial accounting and team management. Good knowledge of taxation and audit.
• Ability to work under pressure, meet tight deadlines, operate independently with strong analytical skills and attention to detail.
• Fluent in both written and spoken English to communicate with stakeholders and possess good interpersonal skills. Strong leadership abilities with the capacity to collaborate across all levels.
• Knowledge of ERP accounting system.
• Proficient in Microsoft Office applications.

Job Description:

· Lead R&D Projects: Drive the design, development, and innovation of interventional medical devices, ensuring projects are completed on time, within scope, and budget.

· Product Development: Oversee the product development lifecycle including feasibility studies, prototyping, preclinical and clinical validation, design for manufacturability (DFM), and regulatory approvals.

· Technical Leadership: Provide technical direction, mentoring, and leadership to a multidisciplinary team of professionals and engineers.

· Collaboration: Work closely with cross-functional teams (clinical, regulatory, manufacturing, marketing, and quality) to ensure seamless product development and alignment with business goals.

· Regulatory Compliance: Ensure that products comply with relevant regulatory standards (e.g. FDA, CE Mark, ISO 13485) and manage interactions with regulatory bodies.

· Innovation and Strategy: Identify emerging trends and technologies in the interventional medical device field, incorporating them into product development strategies.

· Vendor and Partner Management: Collaborate with external partners, suppliers, and contract manufacturers to achieve product development goals.

· Budget and Resource Management: Manage the R&D budget, resource allocation, and project prioritization to optimize development efficiency and output.

· Risk Management: Identify and mitigate technical and project risks throughout the development process.

Requirements:

· Bachelor Degree in Biomedical Engineering, Mechanical Engineering, or related field. Master’s or Ph.D. preferred.

· Minimum of 10 years of experience in R&D within the medical device industry, with at least 5 years focused on interventional medical devices (e.g. catheters, stents, Sheaths, etc.).

· Proven track record of leading product development from concept to market launch.

· Strong knowledge of regulatory requirements and quality systems for medical devices (e.g., FDA, CE Marking, ISO 13485).

· Experience managing R&D teams, including engineers, scientists, and technical staff.

· Excellent leadership, communication, and organizational skills.

· Strong problem-solving abilities and a high level of technical competence in medical device engineering.

· Ability to manage multiple projects simultaneously, balancing technical challenges and business priorities.

· Familiarity with Design Control, Risk Management, and Human Factors Engineering processes.

Job Description

· Lead, coach and develop the precision engineering team to build a high performing and motivated team.

· Provide technical guidance and support in the design and development of medical device system and precision components.

· Develop initiatives to enhance productivity, quality/yield improvements and cost reduction.

· Continuously evaluate and improve engineering processes and workflows.

· Implement best practices, advanced manufacturing techniques and methodologies. Stay updated with the latest technologies and industry trends.

· Overseas machining projects, process and tool selection.

· Lead in equipment qualification and process validationand engineering change.

· Work closely with NPI, Quality, Supply Chain on RFQ, First Article approval and part qualification. Liaise with customer on new part development activities.

· Implement and maintain good quality processes.

· Ensure compliance with medical device industry standards and regulations.

· Coordinate with other departments to align project goals and requirements.

· Manage resources and prioritizing tasks to meet project deadlines.

· Communicate effectively with stakeholders, including board members, clients, and team members.

· Develop and manage the department's budget.

· Encourage a culture of continuous improvement and innovation

· Perform other tasks as assigned by the supervisor

Requirements:

· Bachelor’s degree in mechanical engineering or equivalent.

· Minimum 10 years’ of relevant Precision Engineering working experience.

· Good knowledge in milling tooling and machining process.

· Experienced in medical device industry is preferred.

· Strong knowledge of precision machining, metrology, and CAD/CAM software

· Familiarity with Geometric Dimensioning and Tolerancing and other precision engineering standard

· Leadership skill.

· Project Management skills.

· Listening and Communication skills.

· Problem-solving and Decision-making skills.

· People Management/Development skills.

• Perform qualification validation of medical device sterilization related equipment and processes
• Perform the release of sterilization batches in accordance to relevant ISO standards
• Ensure the compliance of equipment in accordance to Calibration and Preventive Maintenance requirements.
• Perform complaint handling, investigate root cause of complaint, and perform Corrective Action and Preventive Action as necessary.
• Handle non-conformances and perform disposition of rejected parts, trend yield and rejects, investigate root cause of non-conformance and perform Corrective Action and Preventive Action as necessary.
• Initiate and/or execute engineering changes in compliance with Engineering Change Control procedures
• Participate in Process Failure Mode Effect and Analysis team to mitigate product risk arising from manufacturing
• Participate in external and internal audit to ensure company quality system is effective
• Participate in continuous improvement programs such as 6S program, yield improvement projects etc.
• Support new production introduction as a team member representing quality
• Perform other tasks as assigned by the supervisor

Education

• Bachelors Degree in Engineering, Science (e.g. Microbiology) or equivalent

Experience

• Work experience as a sterilization engineer in a medical device manufacturing environment
• Experience with qualification validation of equipment and processes for sterilization of medical device
• Working knowledge of ISO11135 EtO Sterilization for Medical Devices and/or any other relevant standards such as ISO11137 Gamma Sterilization
• ISO13485 Internal auditor

Skills

• Statistical Analysis (Hypothesis Testing, ANOVA, Gage R&R, DOE etc)
• Root cause analysis (Kepner-Tregoe, 5-Why, 6M etc)
• Problem solving techniques (e.g. DMAIC/8D/PDCA/A3 application in continuous improvement)
• Competent with general PC and Office software application

· Handle sales activities/quotations for assigned account.

· Handle and grow existing customers/ new development customers (Machining and Contract Manufacturing) with strategic growth of 15%-20%.

· Manage customer account status & credit control for assigned account.

· Achieve assigned sales target and consistently follow up for purchase order after quotation is submitted to customer.

· Work with cross functional departments for customer request /new RFQ as per SOP0038.

· Review order fulfilment as per SOP0039 and back-up support for sales coordinator in order fulfilment that enable smooth daily operations.

· Maintain & service customers satisfaction as per SOP0040.

· Review consolidation of pricing & forecasting and work with customers in fulfilling the forecast.

· Participate in weekly / bi-weekly / monthly sales call with customers with the aim to ensure business needs are on schedule and to arrest any potential / new issues by customers relating to sales and revenue.

· Understand and work with multi-level bill of materials (BOM).

· Collaborating with the design, production, supply chain, engineering or R & D departments of the company to determine how products and services could be made or modified to suit the needs of the customer.

· Selling on technologically and scientifically company core capabilities to covert to product sales.

· Maintain and ensure Sales and Marketing annual operating budget did not exceed per HOD prevailing directive.

· Managing close relationship with various departments taking deliverables as top priority.

Any other ad-hoc duties as assigned by supervisor.

Minimum Diploma in Mechanical/Manufacturing Engineering or its equivalent.

Minimum 1 year of relevant working experience.

1. Technical and Technological Skills

· Knowledge in Navision system platform.

· Strong oral and written communication skills.

· Basic MS Office proficiency.

· Provide quality customer service that meets customer needs and expectations.

· Able to accomplish sales-related reports and presentations.

2. Personal Qualities (Soft Skills):

· Customer-focused and results-driven.

· Able to work in different time zone for customers weekly conference calls.

· Able to work independently or with the team.

· Good communication and interpersonal skills in building and maintaining both internal and external relationships.

· Open to explore and decipher new things for professional growth.

Job Descriptions

• Assist the department head of Quality in the implementation of and maintenance of the Company Quality Management Systems (QMS) in accordance with ISO 13485 standard and other applicable regulatory requirements.
• Assist the department head of Quality to coordinate external audits conducted by customers and notified/ regulatory bodies. Work with various departments to ensure timely closure of any audit findings or observations.
• Coordinate Engineering Change activities in compliance with Engineering Change procedure and ensure correct revision of drawings, specifications, and documents.
• Ensure all quality documents and records are kept in compliance with Document Control and Record Control procedures.
• Conduct New Employees’ Orientation (NEO) Training on Quality Policy, Quality Objectives, Good Documentation Practice and Data integrity, Document Control and Record Control.
• Consolidate quality data, quality issues and trends for monthly quality metrics reporting.
• Assist department Head of Quality to prepare Management Review semi-annually.
• Track CAPA and any actions arising from Internal Audit, coordinate with responsible parties to ensure timely closure of action items.
• Liaise with 3rd party Notification or Regulatory Bodies for certification and regulatory activities. Track and monitor Regulatory Bodies, such as FDA/ HAS for regulatory updates or any changes to their requirements.
• Perform other tasks as assigned by the Supervisor

Requirement:

• Diploma in Engineering, Science or equivalent

Experience:

• Minimum 1 year working experience in quality management systems and applications.
• Knowledge and experience working within a regulated and structured environment.
• Work experience as Quality System Executive in a medical device manufacturing environment. (Candidates with more experience can be considered for Senior Quality System Executive position)
• Experience with handling ISO13485 audit as an auditee

Skills :

• ISO13485 Internal Auditor
• Root cause analysis (Kepner- Tregoe, 5-Why, 6M etc)
• Problem solving techniques (eg: DMAIC/8D/PDCA/A3 application in continuous improvement)
• Competent with general PC and office software application
• Proficiency in MS Office.

· Create quality inspection plans and work instructions for incoming, In-process or outgoing parts to ensure that components and products conform to specifications.

· Define training plan, train QC supervisors, QC technicians and QC inspectors to perform dimensional/functional inspection in accordance to work instructions.

· Perform First Article Inspection for newly inducted materials and parts.

· Perform qualification validation of equipment, processes and test methods

· Ensure the compliance of equipment and tools use during inspection in accordance to Calibration and Preventive Maintenance requirements.

· Participate in Process Failure Mode Effect and Analysis team to mitigate product risk arising from manufacturing

· Perform complaint handling, investigate root cause of complaint and perform Corrective Action and Preventive Action as necessary.

· Handle non-conformances and perform disposition of rejected parts, trend yield and rejects, investigate root cause of non-conformance and perform Corrective Action and Preventive Action as necessary.

· Maintain the manufacturing environment and perform gowning as necessary when working in controlled manufacturing environment e.g. clean room.

· Initiate and/or execute engineering changes in compliance with Engineering Change Control procedures

· Participate in external and internal audit to ensure company quality system is effective

· Participate in continuous improvement programs such as 6S program, yield improvement projects etc.

· Support new production introduction as a team member representing quality

· Perform other tasks as assigned by the supervisor

· Work experience as a quality engineer in a medical device manufacturing environment

(Candidates with Diploma in Engineering. Science or equivalent can be considered for Assistant Quality Engineer position. Candidates with more experience can be considered for Senior Quality Engineer position)

· Experience with qualification validation of equipment, processes and test methods for new product introduction

• Implement Plant-Wide Automation, Process Flow and Workplace Layout.
• Manage Automation Line and Equipment.
• Provide technical support to production line and implement technical and maintenance procedures.
• Design of Layout, Mechanical Parts, Jigs and Fixtures using Solid Works.
• PLC programming on Omron NJ series or other brand. Lead & direct technicians on operation & trouble shoot of automation line & equipments.
• Documents & file process changes, start up forms, PM schedules, trouble shooting & service records, etc.
• Leads & drives Engineering changes & improvement projects with internal & external customers.
• Manages equipment yield, cycle time & output of production line.
• Manage automation and equipment spare parts.
• Perform other tasks as assigned by the supervisor.

Requirements

Education

• Diploma / Degree in Engineering.

Experience

• Minimum 2 years’ of relevant working experience.

Skills

• PLC programming on Omron NJ series or other brand.
• Solid Works.
• Problem Solving skill.
• Critical Thinking and Coaching Skills.

Job Description

· Handle sales activities/quotations for assigned account.

· Handle and grow existing customers / new development customers (Machining and contract Manufacturing) with strategic growth of 15% - 20%.

· Manage customer account status & credit control for assigned account.

· Achieve assigned sales target and consistently follow up for purchase order after quotation is submitted to customer.

· Work with cross functional departments for customer request /new RFQ as per SOP0038.

· Review order fulfilment as per SOP0039 and back-up support for sales co-ordinator in order fulfilment that enable smooth daily operations.

· Maintain & service customer satisfaction as per SOP0040.

· Review consolidation of pricing & forecasting and work with customers in fulfilling the forecast.

· Participate in weekly / bi-weekly / monthly sales call with customers with the aim to ensure business needs are on schedule and to arrest any potential / new issues by customers relating to sales and revenue.

· Understand and work with multi-level Bill of Materials.

· Collaborating with the design, production, supply chain, engineering or R & D departments of the company to determine how products and services could be made or modified to suit the needs of the customer.

· Selling on technologically and scientifically company core capabilities to covert to product sales.

· Maintain and ensure Sales and Marketing annual operating budget did not exceed per HOD prevailing directive.

· Managing close relationship with various departments taking deliveries as top priority.

· Any other ad-hoc duties assigned by the supervisor.

Requirements

· Minimum Diploma in Mechanical/Manufacturing Engineering or its equivalent

· Minimum 1 year of relevant working experience.

Skills

1. Technical and Technological Skills

· Knowledge in Navision system platform.

· Strong oral and written communication skills.

· Basic MS Office proficiency.

· Provide quality customer service that meets customer needs and expectations.

· Able to accomplish sales-related reports and presentations.

2. Personal Qualities (Soft Skills):

· Customer-focused and results-driven.

· Able to work independently or with the team.

· Good communication and interpersonal skills in building and maintaining both internal and external relationships.

· Open to explore and decipher new things for professional growth.

· Responsible for providing hands-on support in the analysis, design, development, testing and implementation of custom web applications using Microsoft technologies and tools such as Power Platform.

· Assist the management and maintenance of on-premise and cloud-based software systems in the company.

· Providing change management, validations and testing for existing applications and software systems.

· Provide a point of escalation with support for L1 / L2 support, and liaise with external vendors for L3 support for systems.

· Participate in external and internal audit to ensure software and systems used in the company are effective and validated.

· Create and maintain documentations and compliance for data and systems with reference to industry best practices.

· Reviewing software design architecture and updating technical documents.

Perform other tasks as assigned by the supervisor.

Experience:

• 3 or more years with RDBMS and NoSQL databases
• 3 or more years of experience with object-oriented languages (Python, JavaScript, C# .etc)
• Preferred working experience in MedTech / Manufacturing Industry

Skills

• Microsoft Certified Systems Engineer (MCSE)
• Experienced in building and maintaining software systems
• Experienced with Microsoft-based stack (M365, Power Platform, Azure, Dataverse, Microsoft SQL Server, Dynamics 365 Business Central)
• Knowledge of best practices in ICT operations and systems management
• Excellent problem solving and troubleshooting skills
• Process orientated with great documentation practices
• Communication skills, especially for translating technical concepts to non-technical business leaders
• Ability to work on a dynamic, action-focused team that has concurrent projects

JOB RESPONSIBILITIES

· Lead new product and manufacturing transfer activities, setup of medical device service & repair facility

· Implement new production / service/ project initiative and manage budget and timeline.

· Liaise with customer on all new product development/ service & repair activities

· Perform intermediary role between Research & Development (R&D) & manufacturing and service & repair.

· Lead and provide direction to Cross Functional Team.

· Champion to lead & develop from First Article / prototypes to customer's approval.

· Work closely with Supplier Chain, Operations & Quality on supplier qualification, Process Failure Mode Effects Analysis (PFMEA), equipment qualification and process validation, establish service & repair processes

· Perform other tasks as assigned by the supervisors.

JOB REQUIREMENTS

· Minimum Degree in Engineering

· Minimum 3 years of relevant working experience

· Experience in NPI & Project Management

· Familiar with the requirement of medical device service & repair center and its operating process

· Project Management skill

· Communication and leadership skills

· Problem Solving and decision-making skills

· MS Project skill

· Process Failure Mode Effects Analysis (PFMEA) and process validation skill

JOB RESPONSIBILITIES

· Lead new product and manufacturing transfer activities, setup of medical device service & repair facility

· Implement new production / service/ project initiative and manage budget and timeline.

· Liaise with customer on all new product development/ service & repair activities

· Perform intermediary role between Research & Development (R&D) & manufacturing and service & repair.

· Lead and provide direction to Cross Functional Team.

· Champion to lead & develop from First Article / prototypes to customer's approval.

· Work closely with Supplier Chain, Operations & Quality on supplier qualification, Process Failure Mode Effects Analysis (PFMEA), equipment qualification and process validation, establish service & repair processes

· Perform other tasks as assigned by the supervisors.

JOB REQUIREMENTS

· Minimum Degree in Engineering

· Minimum 3 years of relevant working experience

· Experience in NPI & Project Management

· Familiar with the requirement of medical device service & repair center and its operating process

· Project Management skill

· Communication and leadership skills

· Problem Solving and decision-making skills

· MS Project skill

· Process Failure Mode Effects Analysis (PFMEA) and process validation skill