Sr. Manufacturing Engineer at Boston Scientific Corporation Malaysia

Carlsbad, California, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Mar, 26

Salary

0.0

Posted On

18 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Lean Manufacturing, Six Sigma, Value Stream Mapping, Kaizen, Minitab, FMEA, Fishbone, Process Mapping, Manufacturing Process Development, Mechanical Design Principles, FDA Regulations, CAD Software, Risk Management, ISO 14971, Supplier Management, Biomedical Product Development, Medical Device Design

Industry

Medical Equipment Manufacturing

Description

Evaluate current console manufacturing practices and identify those needing improvement. Lead operations to increase production capacity and implement new efficient processes. Analyze and design sequence of operations and workflow to improve efficiencies and establish methods for maximum utilization of production facilities and personnel. Use Lean Manufacturing Methodology, including Value Stream Mapping and Kaizen events. Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc. Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost and improve productivity. Represent Process Engineering in assigned R&D and Project Team meetings for technology transfers and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing. Performs or manages process validations (IQ/OQ, OQ, PQ). Troubleshoot production line issues related to yield, quality, and throughput. Leads scaling up processes from development to full scale manufacturing. Supports evaluation of NCR, CAPA, SCAR, Failure investigation and Deviation requests arising from Contract Manufacturers/Suppliers. Creates/Updates manufacturing instructions, routings, bills of materials and SOPs and performs training when required. M.S Engineering degree desired or equivalent experience in related job field 5+ yrs (Engineer II) Biomedical product or medical device development experience. Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus. Proficient in CAD software, preferably SolidWorks. Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred. Proficient in Risk Management according to ISO 14971 Proficiency in Minitab Hands-on experience managing suppliers and/or contract manufacturers a plus.

Responsibilities

Evaluate and improve console manufacturing practices while leading operations to increase production capacity. Responsible for process development, validation, and troubleshooting production line issues.