Boston Scientific

Medical devices maker for interventional specialties

Junior Manufacturing Engineer

Manufacturing EngineeringConfirmed live in the last 24 hours

Full-timeGeorge Town, Penang, MalaysiaNo salary listedIn-person

About the Job

Requirements

A Bachelor's degree in Engineering is required; Mechanical, Chemical, Biomedical, or a related Engineering discipline is preferred.
Two to four years of relevant work experience in a manufacturing, medical device, or regulated-industry environment is required.
Demonstrates a fundamental understanding of process and product technologies, with the ability to support process development, optimization, validation, and troubleshooting activities.
Able to provide technical input under guidance for the selection, development, qualification, and implementation of equipment, tooling, materials, and manufacturing processes.
Knowledge of engineering problem-solving methodologies, process improvement techniques, and root cause analysis.
Strong analytical, communication, and teamwork skills, with the ability to collaborate effectively in a cross-functional environment.

Responsibilities

Works closely with Research and Development and Manufacturing to develop robust, capable, cost-effective, and safe manufacturing processes, equipment, materials, and products, and supports the transfer of new products and processes into commercial production.
Demonstrates basic technical expertise in process and product technologies to support design, optimization, validation, and troubleshooting.
Under supervisory direction, provides input to Equipment Engineering or external equipment, tooling, or material vendors in selecting, designing, and developing new or upgraded equipment, tooling, and materials.
Applies Design for Six Sigma and Define, Measure, Analyze, Improve, Control tools with mentor assistance to characterize, optimize, and troubleshoot process equipment and technology performance.
Supports the development and execution of experimentation and testing to characterize, optimize, and troubleshoot processes and equipment; summarizes, analyzes, and draws conclusions from test results to achieve technical resolution.
Supports introduction of new processes, equipment, and materials, including installation, calibration, environmental, health, and safety assessment, debugging, and associated process and quality-system documentation, including technical and process work instructions.
Applies Lean methodologies and process-improvement tools with mentor assistance to identify and eliminate wasteful process steps and develop efficient, cost-effective equipment and processes.
Applies process and equipment validation techniques, process failure mode and effects analyses, and associated regulatory requirements with mentor assistance to support timely, efficient validation.
Supports writing and release of process-validation documentation, including failure mode and effects analyses, validation plans, protocols, and reports.
Supports execution and documentation of validation builds, coordinates testing of validation units, and compiles, analyzes, and reports validation results.
With mentor assistance, ensures compliance with regulations governing quality systems.
For an assigned calibration engineering role, provides equipment calibration services to meet company objectives while maintaining measurement traceability to nationally recognized equipment-calibration standards and practices.
Supports the Technical Subject Matter Expert for the Calibration group and internal and external audits.
Maintains competency in the Calibration Management System.
Performs calibration functions and sets day-to-day functions for the calibration group.
Supports research and acquisition of new standards and other capital equipment, providing detailed justifications and cost analyses as required.
Develops technical engineering reports and calibration procedures, and trains department technicians on new calibration procedures.
Provides support and guidance to calibration technicians performing moderately complex equipment calibrations.
Supports calibration-laboratory needs, including environmental control and new technologies.
Supports the Senior Metrology Engineer and management in developing department fiscal-year budgets.
Communicates calibration status to the Operations Manufacturing Engineering function.
Maintains compliance with all quality requirements in all aspects of work.
Drives standard work across calibration activities.

Desired Qualifications

Familiarity with quality systems, regulatory requirements, and continuous-improvement practices is an added advantage.

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 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.

Job Requirements:

Bachelor’s Degree in Engineering, preferably in Mechanical, Chemical, Biomedical, or a related Engineering discipline.
2–4 years of relevant working experience in a manufacturing, medical device, or regulated industry environment.
Demonstrates a fundamental understanding of process and product technologies, with the ability to support process development, optimization, validation, and troubleshooting activities.
Able to provide technical input under guidance for the selection, development, qualification, and implementation of equipment, tooling, materials, and manufacturing processes.
Knowledge of engineering problem-solving methodologies, process improvement techniques, and root cause analysis.
Strong analytical, communication, and teamwork skills, with the ability to collaborate effectively in a cross-functional environment.Familiarity with quality systems, regulatory requirements, and continuous improvement practices is an added advantage.
This is additional role.

About Us

As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

About the Company

Boston Scientific

Medical devices maker for interventional specialties

Boston Scientific designs and makes medical devices used in procedures across cardiology, endoscopy, urology, and neuromodulation. Its products help doctors diagnose and treat conditions by guiding minimally invasive interventions and delivering therapies inside the body, with revenue from hospitals and clinics. The firm differentiates itself through a broad, global portfolio and heavy ongoing investment in research and development to expand capabilities and address complex health issues. Its goal is to improve patient care by providing reliable, effective medical devices and solutions that enable clinicians to perform safer, more effective procedures while growing its business.

Company size: 10,001+
Company stage: IPO
Headquarters: Marlborough, MA
Founded: 1979

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