Manufacturing Technician Iii jobs at Boston Scientific in Malaysia

Purpose Statement:

Under supervisory direction, works closely with R&D and Manufacturing in the development of robust, capable, cost effective & safe manufacturing processes. equipment, materials and products and supports efficient and effective transfer of new products & processes into commercial production.

Job Description:

• Demonstrates basic technical expertise on process/product technologies to support design, optimization, validation and troubleshooting of those technologies.

• Under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.

• Demonstrates good working knowledge of DFSS/DMAIC tools and, with mentor assistance, applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.

• Supports the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of processes and equipment. and summarizes, analyses and draws conclusions from test results leading to effective technical resolution.

• Supports the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.

• With mentor assistance demonstrates good working knowledge and application of Lean methodologies, and process improvement tools to assist in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.

• With mentor assistance demonstrates good working knowledge and application of Process and equipment validation techniques, PFMEA’s, and associated regulatory requirements and applies this knowledge in the support of efficient & timely validation of equipment and processes.

• Under supervision supports the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.

• Under supervision, supports execution and documentation of validation builds, co-ordinates testing of validation units and compiles, analyses and reports on the validation results.

• With mentor assistance ensures compliance with all the regulations governing the quality systems.

• For individual who is assigned calibration engineering role only:

• Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices.

• Supporting Technical SME for Calibration group and for internal and external Audit

• Competent on Calibration Management System

• Perform calibration functions and sets day to day function for calibration group

• Supports the research and acquisition of new standards and other capital equipment, providing detailed justifications and cost analysis as required.

• Develops technical engineering reports and calibration procedures and trains department technicians on new calibration procedures.

• Provides support and guidance to calibration technicians in performing moderately complex equipment calibrations.

• Supports calibration lab needs regarding such issues as environmental control and new technologies.

• Supports Senior Metrology Engineer and Management to develop the department fiscal year budgets.

• Communicates with the Operations ME function on calibration status.

• Build Quality into all aspects of work by maintaining compliance to all quality requirements

• Drive “Standard Work” in all aspect of Calibration activity.

Job Requirements:

• Candidate required possess at least Bachelor's Degree in Engineering or any related field.

• Required at least 1 ~ 3 years of working experience in related field.

• Demonstrates basic technical expertise on process/product technologies to support design, optimization, validation and troubleshooting of those technologies.

• Able to work under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new product.

Job Responsibilities:

• To identify, order and commission the key process equipment to CGMP in the Operations Engineering Cycle to meet key business objectives

• Engineering process owner for the area.

• Develop and modify manufacturing documentation and procedures to support commercial products as well as the introduction of new products to the production floor (assembly procedures, BOMs, etc.)

• Ensure that new products introduced to the production floor meet business, quality, output and cost goals and objectives

• Develop and modify various manufacturing processes to improve product and process quality and output

• Ensure product/process requirements are met for component, assembly, tooling and supplier specifications

• Perform product/process/vendor qualification activities as required

• Support material discrepancy review and disposition activities (MRB) for existing commercial products

• Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company.

• Eliminate/reduce product/process defects and improve yields. Strong problem solver for technical problems in the area, solves problems from basic engineering principles, theories and concepts.

• Demonstrate a primary commitment to patient safety and product quality

• Support all quality and corrective/preventive actions initiatives (NCEP, CAPA) to achieve quality goals

• Maintain a valid capacity model in co-operation with the line Supervisor and conduct adequate advance planning for required capital

• Capable of training cross functional team members including, engineers, technicians and product builders

• Knowledge of project management.

• Interacts cross functionally and with internal and external customers.

• Ability to develop expert knowledge on BSC systems.

• Willing to travel internationally as part of project team.

• For individual who is assigned calibration engineering role only:

• Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices.

• Technical SME for Calibration group and SME for internal and external Audit.

• SME for Calibration Management System.

• Perform calibration functions and sets day to day function for calibration group.

• Researches, recommends, and acquires new standards and other capital equipment, providing detailed justifications and cost analysis as required.

• Develops technical engineering reports and complex technical calibration procedures and trains department technicians on new calibration procedures.

• Works directly with Equipment Engineering and Manufacturing Engineering departments to advise on equipment selection, design accommodations for calibration of new equipment and appropriate measurement techniques.

• Provides support and guidance to calibration technicians in performing complex equipment calibrations.

• Supports calibration lab needs regarding such issues as environmental control and new technologies.

• Works with Management to develop the department fiscal year budgets.

• Communicates with the Operations ME function on calibration status.

• Build Quality into all aspects of work by maintaining compliance to all quality requirements.

• Drive “Standard Work” in all aspect of Calibration activity.

Job Requirements:

1. Candidate require process at least Bachelor’s degree in Mechanical Engineering. Preferable in mechanical, Chemical or biomedical.

2. Candidate require has at least 8 years of experience in related field.

3. Prefer candidate from medical device or other regulated industry experience.

4. Demonstrate ability to generate manufacturing documentations, specifications and technical reports in a concise manner, hands on and action-oriented engineer with strong analytical skill.

5. Skill required:

1. Leadership.
2. Exhibits strong engineering knowledge, problem-solving skills.
3. Experienced in sustaining and production working environments.5. Experience in the medical devices manufacturing industry is a plus

Key Responsibilities

• Demonstrates basic technical expertise on process/product technologies to support design, optimization, validation and troubleshooting of those technologies.
• Under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
• Demonstrates good working knowledge of DFSS/DMAIC tools and, with mentor assistance, applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.
• Supports the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of processes and equipment. and summarizes, analyses and draws conclusions from test results leading to effective technical resolution.
• Supports the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
• With mentor assistance demonstrates good working knowledge and application of Lean methodologies, and process improvement tools to assist in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
• With mentor assistance demonstrates good working knowledge and application of Process and equipment validation techniques, PFMEA’s, and associated regulatory requirements and applies this knowledge in the support of efficient & timely validation of equipment and processes.
• Under supervision supports the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.
• Under supervision, supports execution and documentation of validation builds, co-ordinates testing of validation units and compiles, analyses and reports on the validation results.
• With mentor assistance ensures compliance with all the regulations governing the quality systems.
• For individual who is assigned calibration engineering role only:
• Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices.
• Supporting Technical SME for Calibration group and for internal and external Audit
• Competent on Calibration Management System
• Perform calibration functions and sets day to day function for calibration group
• Supports the research and acquisition of new standards and other capital equipment, providing detailed justifications and cost analysis as required.
• Develops technical engineering reports and calibration procedures and trains department technicians on new calibration procedures.
• Provides support and guidance to calibration technicians in performing moderately complex equipment calibrations.
• Supports calibration lab needs regarding such issues as environmental control and new technologies.
• Supports Senior Metrology Engineer and Management to develop the department fiscal year budgets.
• Communicates with the Operations ME function on calibration status.
• Build Quality into all aspects of work by maintaining compliance to all quality requirements
• Drive “Standard Work” in all aspect of Calibration activity.

Requirements

• Minimum Degree in Engineering
• 3-5 years of experience in manufacturing / process engineering. Prior experience in the medical device industry is preferred.
• Required skills: Problem Solving, analytical skill, project management, critical thinking, NPI, people leadership
• Experience in product transfer will be added advantage.

Responsibilities

• Maintain and monitor Capital Equipment opportunity funnel from lead through deal closure; manage renewal timelines and upsell tracking
• Collaborate with global product and marketing teams to localize materials for local markets, support service program launches, and ensure timely rollouts
• Provide regional coordination for tools, presentations, sales aids, and training assets
• Act as the central resource for KPI tracking, quote-to-close metrics, and pricing consistency
• Ensure best practice sharing and standardized processes across countries for efficient execution
• Serve as a key enabler to reduce administrative burden on country teams and frontline sales

Requirements:

• Minimum Bachelor Degree in any discipline
• Minimum 3–5 years of experience in sales support, marketing, or product coordination in relation to capital equipments
• Proficient in CRM tools (e.g., Salesforce) or equivalent, quoting tools and powerpoint
• Strong attention to detail and experience working with regional or global teams
• Excellent communication skills and ability to work in a fast-paced, matrixed environment
• Experience in medical devices or capital equipments industry is preferred

Quality System Requirements:

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Purpose Statement:

Entry Level Engineer who provides daily support of products, processes, materials, and equipment in order to achieve production goals (i.e. quality, delivery, cost, productivity, and safety).

Job Description:

• Demonstrates basic technical expertise on process/product technologies to support design, optimization, validation and troubleshooting of those technologies.

• Under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.

• Demonstrates good working knowledge of DFSS/DMAIC tools and, with mentor assistance, applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.

• Supports the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of processes and equipment. and summarizes, analyses and draws conclusions from test results leading to effective technical resolution.

• Supports the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.

• With mentor assistance demonstrates good working knowledge and application of Lean methodologies, and process improvement tools to assist in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.

• With mentor assistance demonstrates good working knowledge and application of Process and equipment validation techniques, PFMEA’s, and associated regulatory requirements and applies this knowledge in the support of efficient & timely validation of equipment and processes.

• Under supervision supports the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.

• Under supervision, supports execution and documentation of validation builds, co-ordinates testing of validation units and compiles, analyses and reports on the validation results.

• With mentor assistance ensures compliance with all the regulations governing the quality systems.

• For individual who is assigned calibration engineering role only:

• Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices.

• Supporting Technical SME for Calibration group and for internal and external Audit

• Competent on Calibration Management System

• Perform calibration functions and sets day to day function for calibration group

• Supports the research and acquisition of new standards and other capital equipment, providing detailed justifications and cost analysis as required.

• Develops technical engineering reports and calibration procedures and trains department technicians on new calibration procedures.

• Provides support and guidance to calibration technicians in performing moderately complex equipment calibrations.

• Supports calibration lab needs regarding such issues as environmental control and new technologies.

• Supports Senior Metrology Engineer and Management to develop the department fiscal year budgets.

• Communicates with the Operations ME function on calibration status.

• Build Quality into all aspects of work by maintaining compliance to all quality requirements

• Drive “Standard Work” in all aspect of Calibration activity.

Job Requirements:

• Candidate required possess at least Bachelor's Degree in Engineering. Preferable in mechanical, Chemical or biomedical.

• Required at least 1 ~ 3 years of working experience in related field.

• Demonstrates basic technical expertise on process/product technologies to support design, optimization, validation and troubleshooting of those technologies.

• Able to work under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new product.

• 3 permanent vacant available.

Job Description:

• To identify, order and commission the key process equipment to CGMP in the Operations Engineering Cycle to meet key business objectives

• Engineering process owner for the area

• Develop and modify manufacturing documentation and procedures to support commercial products as well as the introduction of new products to the production floor (assembly procedures, BOMs, etc.)

• Ensure that new products introduced to the production floor meet business, quality, output and cost goals and objectives

• Develop and modify various manufacturing processes to improve product and process quality and output

• Ensure product/process requirements are met for component, assembly, tooling and supplier specifications

• Perform product/process/vendor qualification activities as required

• Support material discrepancy review and disposition activities (MRB) for existing commercial products

• Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company

• Eliminate/reduce product/process defects and improve yields. Strong problem solver for technical problems in the area, solves problems from basic engineering principles, theories and concepts.

• Support all quality and corrective/preventive actions initiatives (NCEP, CAPA) to achieve quality goals

• Capable of training cross functional team members including, engineers, technicians and product builders

• Knowledge of project management

• Interacts cross functionally and with internal and external customers

• Ability to develop expert knowledge on BSC systems.

• Willing to travel internationally as part of project team.

• For individual who is assigned calibration engineering role only:

• Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices.

• Technical SME for Calibration group and SME for internal and external Audit

• SME for Calibration Management System

• Manage and Perform calibration functions. Sets day to day function for calibration group

• Researches, recommends, and acquires new standards and other capital equipment, providing detailed justifications and cost analysis as required.

• Develops technical engineering reports and complex technical calibration procedures and trains department technicians on new calibration procedures.

• Works directly with Equipment Engineering and Manufacturing Engineering departments to advise on equipment selection, design accommodations for calibration of new equipment and appropriate measurement techniques.

• Provides support and guidance to calibration technicians in performing complex equipment calibrations.

• Manage calibration lab needs regarding such issues as environmental control and new technologies.

• Works with Senior Metrology Engineer and Management to develop the department fiscal year budgets.

• Communicates with the Operations ME function on calibration status.

• Build Quality into all aspects of work by maintaining compliance to all quality requirements

Job Requirements:

• Candidate required possess at least Bachelor's Degree in Engineering.

• Required at least 5 ~ 8 years of working experience in related field.

• Prefer candidate with possesses hands-on experience in manufacturing and process engineering, with a proven track record in problem-solving and process improvement. Additional advantage includes experience in people management.

• Skill required: Strong analytics skill, problem Solving and Process Improvement knowledge and leadership skill.

Job Respondsibilities:

• To identify, order and commission the key process equipment to CGMP in the Operations Engineering Cycle to meet key business objectives

• Engineering process owner for the area

• Develop and modify manufacturing documentation and procedures to support commercial products as well as the introduction of new products to the production floor (assembly procedures, BOMs, etc.)

• Ensure that new products introduced to the production floor meet business, quality, output and cost goals and objectives

• Develop and modify various manufacturing processes to improve product and process quality and output

• Ensure product/process requirements are met for component, assembly, tooling and supplier specifications

• Perform product/process/vendor qualification activities as required

• Support material discrepancy review and disposition activities (MRB) for existing commercial products

• Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company

• Eliminate/reduce product/process defects and improve yields. Strong problem solver for technical problems in the area, solves problems from basic engineering principles, theories and concepts.

• Support all quality and corrective/preventive actions initiatives (NCEP, CAPA) to achieve quality goals

• Capable of training cross functional team members including, engineers, technicians and product builders

• Knowledge of project management

• Interacts cross functionally and with internal and external customers

• Ability to develop expert knowledge on BSC systems.

• Willing to travel internationally as part of project team.

• For individual who is assigned calibration engineering role only:

• Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices.

• Technical SME for Calibration group and SME for internal and external Audit

• SME for Calibration Management System

• Manage and Perform calibration functions.
• Sets day to day function for calibration group

• Researches, recommends, and acquires new standards and other capital equipment, providing detailed justifications and cost analysis as required.

• Develops technical engineering reports and complex technical calibration procedures and trains department technicians on new calibration procedures.

• Works directly with Equipment Engineering and Manufacturing Engineering departments to advise on equipment selection, design accommodations for calibration of new equipment and appropriate measurement techniques.

• Provides support and guidance to calibration technicians in performing complex equipment calibrations.

• Manage calibration lab needs regarding such issues as environmental control and new technologies.

• Works with Senior Metrology Engineer and Management to develop the department fiscal year budgets.

• Communicates with the Operations ME function on calibration status.

• Build Quality into all aspects of work by maintaining compliance to all quality requirements

Job Requirements:

• Candidate required possess at least Bachelor's Degree in Engineering.

• Required at least 5 ~ 7 years of working experience in manufacturing or process engineering.

• Proven track record in product transfers, equipment qualification, and process validation.

• Experience in working within a matrix organization and cross-site collaboration.

• Able to work under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new product.

• Prefer candidate with strong project management and technical documentation skills.

• Proficient in validation protocol/report writing (IQ/OQ/PQ).
• Skilled in root cause analysis and process improvement method.
• Effective communication and stakeholder management across global teams.