דרושים Design Assurance Engineer Iii ב-Boston Scientific ב-מלזיה

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
• 5-10 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.

Key Responsibilities

• Collaborates with cross-functional teams to lead and/or support the organization of events and meetings, while following established guidelines, processes, and tools
• Communicates proactively to all levels of management and stakeholders. Ability to handle senior Key Opinion Leader (KOL) communication individually
• In all actions with HCPs, demonstrates a primary commitment to compliant behavior with documented processes and procedures in case of audits
• Fosters strong relationships with key customers, both internal and external
• Serves as a liaison and event resource for initiatives and can communicate clearly and directly to the Senior Leadership when required on activities and progress
• Able to collaborate with identified vendors to ensure that initiatives meet objectives
• Directs and initiates solutions in support of continuous improvement
• Defines, tracks, and maintains budgets. Ensures cost-saving measures and spending within allocated amount. Ability to work resourcefully within budgets
• Maintains and enhances knowledge of meetings, events and tradeshow industry trends and best-in-class practices as related to responsibilities
• Manages and ensures consistency in the Boston Scientific brand

Key Qualifications

• Minimum 5 years of relevant experience
• At least a degree or equivalent
• Familiarity and work experience with markets in the Asia Pacific region. Fluency in an additional language in the Asia Pacific region would be an advantage
• Experience in a corporate environment managing meetings, events and tradeshows. Healthcare experience preferred to understand strict compliance rules
• Strong vendor management skills to be able to deliver projects on deadline and to budget
• High level strategic knowledge of event management software web registration and experience of working on learning platforms required
• Must have demonstrated ability to develop and maintain strong relationships with stakeholders. Good communication skills and ability to use diplomacy and tact to diffuse high tension situations, particularly external contacts/vendors
• Strong communication and multitasking abilities, preference to candidates who can hit the ground running. Ability to guide and mentor junior and in-country teams on processes and documentation
• Ability to work independently and collaboratively to meet deadlines and prepare materials with a high degree of accuracy
• Highly organized, proactive, resourceful, energetic, creative and problem-solving thinker, able to exercise sound judgment
• Ability and flexibility to travel to provide onsite support as required

Purpose Statement:

The successful candidate will work under minimal supervision on 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. This level position requires an extensive knowledge base and a high degree of independence.

Key Responsibilities:

• Demonstrates extensive technical expertise (SME) on product / process technologies to develop solution for design improvement, optimisation, validation and troubleshooting of those technologies.

• Collaborate through developed networks (both internal & external) in assisting engineering teams in the selection, design & development of new product, processes, equipment, tooling and materials.

• Develop / lead the execution of experimentation and testing to enable characterisation, optimization and troubleshooting of processes and equipment; summarises, analyses and draws conclusions leading to effective technical resolution & communication to wider technical community.

• Coordinates/directs 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.

• Lead / support continuous improvement activity – through effective application of Six Sigma & Lean methodologies to assist in the characterization, optimization, troubleshooting and development of efficient, cost effective equipment and processes.

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

• Travel to other sites / vendors as part of technology development & transfer activities.

• Train/Coach peers on the technical aspects of their job; Trains production trainers/operators/manufacturing technicians on new processes.

• Provides floor support for new product builds (e.g., troubleshoots equipment and manufacturing problems).

Requirements:

• Candidate must possess at least a Diploma/ Degree in Engineering, Science or equivalent.

• At least 5 years working experience in Manufacturing environment.

• Prefer candidate with Photonic/ fiber optic background.

• Required skill(s): Equipment Troubleshooting, Problem Solving
  Process Improvement, and Lean Six Sigma.

• Required language(s): Bahasa Malaysia, English.

• 2 full time positions available.

Key Responsibilities:

• Provide support to the validation department in regards to decisions on what systems require validation as well as support the validation/remediation of software installed in the company, maintain the change control of the software and provide guidance in IQ creation and execution.

• Identify areas that may require software validation and advice system owners about validation requirements.

• Analyze areas for improvement and recommend/advice about software solutions

• Maintain procedures related to Software Validation.

Job Requirements:

• Degree in Engineering / Science

• At least 2 years experience in Equipment installation qualification, software validation/ process validation

• Required skills: Basic statistical skills, Minitab, Problem solving

Key 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

Requirements

• Minimum Degree in Engineering
• 9-12 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, direct reports management.
• Proven track record in product transfers, equipment qualification, and process validation.
• Experience in working within a matrix organization and cross-site collaboration.
• Strong project management and technical documentation skills.
• Proficient in validation protocol/report writing (IQ/OQ/PQ).
• Skilled in root cause analysis and process improvement methodologies .
• Effective communication and stakeholder management across global teams
• Experience in product transfer will be added advantage.

Key Responsibilities:

• Provide support to the validation department in regards to decisions on what systems require validation as well as support the validation/remediation of software installed in the company, maintain the change control of the software and provide guidance in IQ creation and execution.

• Identify areas that may require software validation and advice system owners about validation requirements.

• Analyze areas for improvement and recommend/advice about software solutions

• Maintain procedures related to Software Validation.

Job Requirements:

• Degree in Engineering / Science

• At least 2 years experience in Equipment installation qualification, software validation/ process validation

• Required skills: Basic statistical skills, Minitab, Problem solving

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:

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

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

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

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

• Excellent communication skills.