Manufacturing Engineer (Seismiq)

Boston Scientific Gruppe; Batu Kawan; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading medical device company in Malaysia is seeking an experienced process engineer with 5-10 years in manufacturing or process engineering. The ideal candidate will have strong problem-solving and analytical skills, as well as a background in the medical device industry. This role involves supporting design optimization, equipment validation, and ensuring compliance with quality regulations. Competitive compensation and opportunities for professional growth are offered.

Qualifications

• 5-10 years of experience in manufacturing/process engineering.
• Prior experience in the medical device industry is preferred.
• Experience in product transfer is an added advantage.

Responsibilities

• Demonstrates technical expertise to support design and optimization.
• Provides input to equipment/tooling vendors.
• Applies DFSS/DMAIC tools for process optimization.
• Supports development of experimentation and testing.
• Ensures compliance with quality system regulations.

Skills

Problem Solving

Analytical skill

Project management

Critical thinking

NPI

People leadership

Education

Minimum Degree in Engineering

Job description

Press Tab to Move to Skip to Content Link

Select how often (in days) to receive an alert: Create Alert

• 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.

Requisition ID:604222

Job Segment: Medical Device Engineer, Manufacturing Engineer, Medical Device, Environmental Health & Safety, Engineer, Engineering, Healthcare