Manufacturing Engineer

Purpose Statement:

Manufacturing Engineering Department seeking a Manufacturing Engineer II 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.

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.

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.