Boston Scientific

Medical devices maker for interventional specialties

Senior Manufacturing Engineer

Manufacturing EngineeringConfirmed live in the last 24 hours

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

About the Job

Requirements

The candidate must have a bachelor's degree in Engineering; Mechanical, Chemical, or Biomedical Engineering is preferred.
The candidate must have at least 8 years of relevant experience in a manufacturing engineering environment.
The candidate must be able to independently perform a broad range of manufacturing engineering responsibilities and provide technical support for manufacturing operations.
The candidate must be able to prepare and maintain manufacturing documentation, technical specifications, protocols, and reports clearly, accurately, and concisely.
The candidate must have hands-on problem-solving, project management, and execution skills.
The candidate must be able to work effectively in a cross-functional team environment and drive initiatives to successful completion.
The candidate must have strong analytical skills and a continuous improvement mindset focused on operational excellence.
The candidate must be able to plan and organize non-routine tasks, work with minimal supervision, and perform in a fast-paced, time-sensitive, multi-project environment.
The candidate must be able to coach and train technical reports and cross-functional team members, including engineers, technicians, and product builders.
The candidate must be willing to travel internationally as part of a project team.
The candidate must have knowledge of project management.
The candidate must be able to develop expert knowledge of Boston Scientific systems.

Responsibilities

Identify, order, and commission key process equipment to current good manufacturing practice standards within the Operations Engineering Cycle to meet business objectives.
Serve as the engineering process owner for the assigned area.
Develop and modify manufacturing documentation and procedures, including assembly procedures and bills of materials, to support commercial products and introduce new products to the production floor.
Ensure newly introduced products meet business, quality, output, and cost objectives.
Develop and modify manufacturing processes to improve product and process quality and output.
Ensure product and process requirements are met for components, assemblies, tooling, and supplier specifications.
Perform product, process, and vendor qualification activities as required.
Support material discrepancy review and disposition activities for existing commercial products.
Apply specialized field knowledge in leadership roles and develop recognized expertise in an area of specialization.
Eliminate or reduce product and process defects, improve yields, and solve technical problems using basic engineering principles, theories, and concepts.
Maintain a primary commitment to patient safety and product quality.
Support quality and corrective and preventive action initiatives, including NCEP and CAPA, to achieve quality goals.
Maintain a valid capacity model in cooperation with the line supervisor and plan in advance for required capital.
Interact cross-functionally and with internal and external customers.
For individuals assigned a calibration engineering role, provide equipment calibration services while maintaining measurement traceability to nationally recognized calibration standards and practices.
For individuals assigned a calibration engineering role, serve as the technical subject matter expert for the Calibration group, internal and external audits, and the Calibration Management System.
For individuals assigned a calibration engineering role, perform calibration functions and set the day-to-day functions for the calibration group.
For individuals assigned a calibration engineering role, research, recommend, and acquire new standards and capital equipment, providing detailed justifications and cost analyses as required.
For individuals assigned a calibration engineering role, develop technical engineering reports and complex calibration procedures, and train department technicians on new procedures.
For individuals assigned a calibration engineering role, advise Equipment Engineering and Manufacturing Engineering on equipment selection, design accommodations for calibration of new equipment, and appropriate measurement techniques.
For individuals assigned a calibration engineering role, provide support and guidance to calibration technicians performing complex equipment calibrations.
For individuals assigned a calibration engineering role, support calibration laboratory needs, including environmental control and new technologies.
For individuals assigned a calibration engineering role, work with management to develop departmental fiscal-year budgets.
For individuals assigned a calibration engineering role, communicate calibration status to the Operations Manufacturing Engineering function.
Maintain compliance with all quality requirements and build quality into all aspects of work.
Drive standard work in all aspects of calibration activity.

Purpose Statement:

Manufacturing Engineering Department seeking a Senior Manufacturing Engineer to perform all manufacturing engineering duties. The ideal candidate must possess effective verbal, written presentation, negotiation and interpersonal skills. Demonstrate ability to generate manufacturing documentations, specifications and technical reports in a concise manner, hands on and action oriented engineer with strong analytical, critical thinking skills and able to work well under general directions with minimum supervision. The candidate should be data driven, goal oriented and willing to learn and development new skills, able to work in a fast paced, time sensitive, multi-project and results driven environment with multi-disciplinary team interface. The ideal candidate must be able to plan and organize non-routine task. Ability to coach, lead and enhance the productivity of technical reports within the business. Provide a structured framework for training of technical reports. Build collaborative relationships through strong teamwork across the organization.

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 groupResearches, 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:

Bachelor's Degree in Engineering, preferably in Mechanical, Chemical, or Biomedical Engineering.
Minimum 8 years of relevant experience in a manufacturing engineering environment.
Proven ability to independently perform a broad range of Manufacturing Engineering responsibilities and provide technical support for manufacturing operations.
Strong verbal, written, presentation, negotiation, and interpersonal communication skills.
Demonstrated ability to prepare and maintain manufacturing documentation, technical specifications, protocols, and reports in a clear, accurate, and concise manner.
Hands-on, action-oriented individual with strong problem-solving, project management, and execution skills.
Ability to work effectively in a cross-functional team environment and drive initiatives to successful completion.
Strong analytical skills with a continuous improvement mindset and focus on operational excellence

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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