Process Development Engineer Iii jobs at Boston Scientific in Malaysia

Purpose Statement:

Povides leadership and technical guidance to Process Development staff through the management of project teams, technology or specialised function. Function leader for the innovation, design, development and implementation of manufacturing processes, procedures, tooling and equipment for the production and transfer of medical devices. Devotes a portion of time to managerial, leadership, and staff development responsibilities.

Job Responsibilities:

• Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality staff.
• Assists in and/or develops departmental budgets, monitors spending, and ensures that they meet divisional requirements. Participates in periodic business reviews.
• Assists in and/or determines appropriate staffing levels, schedules and resources. Works with functional and divisional management to understand priorities and plans resources and time allocation accordingly.
• Prioritizes and manages execution of multiple department or NPD projects.
• Manages project functional deliverables and ensures technical excellence for new product development.
• Maintains and enhances cross-functional team relationships and works cross-functionally in identifying and resolving engineering/development issues.
• Supports new product success, from divisional project planning through to production launch at the manufacturing site
• Develops departmental metrics and objectives and monitors progress.
• Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
• Ensures visibility and closure of process issues (e.g., capacity, cost, capability, etc.) per NPD milestones.
• Evaluates external technologies and strategically identifies opportunities to implement them internally.
• Supports staff development through a commitment to mentoring and technical leadership.
• Supports the development and implementation of processes that are capable to Six-Sigma level, are optimized using Born Lean tools, and are compliant with all quality / regulatory requirements
• Supports the development and implementation of capital equipment that ensure balance between optimizing site technical capabilities / ROI and include the necessary maintenance procedures to ensure process control
• Collaborates closely with R&D functional peers to ensure that Design for Manufacturability is a key consideration in all product and process design steps

Job Requirements:

• Candidate required to proses at Bachelor Degree or master's in engineering.

• At least 10~12 years of manufacturing and/or process development experience.

• Has proven experience in direct report supervision, functional management, project management, and budgeting.
• Skills: Process development, process improvement, statistical analysis, lean manufacturing, process validation.

Job Respondsibilities:

Participates on project teams to develop clear specifications, evaluates the feasibility of concepts, and provides formal estimates for system designs. Leads and liaises with external design companies to provide engineering solutions for BSC.

• Creates and reviews mechanical designs and detail drawings utilizing parametric modelling and FEA software.

• Coordinates, monitors and documents project designs, estimates, and costs. Complete project deliverables and monitor project schedule and scope changes to assure the team can meet delivery requirements.

• Prepares standard reports/documentation to communicate status and results.

• Leads project teams that include Designers, Engineers and Technicians in the design, assembly, and debug of equipment. Provide leadership role on championing functional best practices.

• Selects materials and coatings for use in automated equipment and tooling. Manages spares usage.

• Designs pneumatic systems and specifies pneumatic components. Identifies electrical components and automated control requirements.

• Assist with completing required FDA/QSR equipment documents including specifications, software validations and qualifications.

• Opportunity to learn or implement industrial controls software.

• Influences and defines functional, departmental/divisional procedures through involvement with cross-functional engineering initiatives.

• Provides training as required to ensure proper operation and maintenance of equipment.

• Incident Management: Manages Equipment failure outlining impact on the business, recovery plan, and resources required.
• Generates weekly and Monthly metrics on Equipment downtime, MTTR, MTBF, Cost, Improvement activity, PM compliance, and resource management.

• Ensure Work carried out as part of Primo is as per procedures – Continue to improve this process.

• Continuously drives the ‘up-skill’ of Maintenance Techs using TSG and creation of set up and maintenance documents.

Job Requirements:

• Candidate required possess at least Bachelor’s Degree in Engineering (Mechanical, Manufacturing, or related field)

• Minimum 8 years of experience in equipment engineering.

• Proven track record in product transfers, equipment qualification, and equipment setup and improvement.

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

• Strong project management and technical documentation skills.
• Proficient in equipment qualification protocol/report writing (ESQ).
• Skilled in root cause analysis and process&equipment improvement methodologies.
• Effective communication and stakeholder management across global teams
• Wiling to travel oversea for training/assignment.

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.