Senior Production Engineer

BIOTRONIK APM II PTE. LTD.; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A leading company in the medical devices sector is seeking a Production Engineer (AME) to oversee technical tasks in project management and production processes. The role will involve collaboration with various departments during the pilot and ramp-up phases, driving process improvements and ensuring compliance with industry standards.

Benefits

Encouragement for entrepreneurial thinking

Opportunity to work in global teams

Professional development opportunities

Qualifications

• Minimum 2 years of relevant experience for degree holders, 8 years for diploma holders.
• Experience in the medical devices industry preferable.
• Familiarity with ISO13485 and GMP standards.

Responsibilities

• Analyze processes and define requirements for specifications.
• Manage process transfer and prepare documentation.
• Monitor KPIs and implement continuous improvement initiatives.

Skills

Statistical skills

Lean Manufacturing

Project Management

Organizational skills

Communication skills

Intercultural skills

Education

Bachelor’s Degree or Diploma in Biomedical, Materials, Chemical, Electronics, Mechanical, or Industrial Engineering

Tools

SAP

MES

Job description

PURPOSE OF THE POSITION

The Production Engineer (AME) is responsible for identifying, formulating, coordinating, monitoring, and following up on technical tasks for assigned projects during transfer and coordination with various departments during the pilot and ramp-up phases.

ESSENTIAL JOB FUNCTIONS

• Analyze assigned processes, define process interfaces and boundaries, and determine requirements for specification-compliant process results through process validations or re-validations, including IQ, OQ, and PQ. Assist the Project Manager in identifying, formulating, coordinating, monitoring, and following up on technical tasks for assigned projects.
• Develop process steps with relevant parties:
• Define routing/workflow content.
• Create descriptions (FPV).
• During product transfer:
• Manage own assigned processes, plan and coordinate with relevant parties for process transfer, and be accountable for timelines and objectives.
• Derive acceptance criteria for process target quantities.
• Prepare production transfer documentation (ERS).
• Demonstrate achievement of process target quantities.
• Release process for serial production.
• At serial production, implement defined plans:
• Monitor key performance indicators, analyze deviations, and initiate corrective actions.
• Conduct continuous improvements for operational performance, including yield enhancement, cycle-time reduction, waste minimization, and productivity gains.
• Monitor climate conditions/process media and collaborate with relevant parties to address deviations or abnormalities.

TECHNICAL COMPETENCIES

Statistical skills:

• Perform hypothesis testing using statistical methods.
• Identify special and common cause variables and take appropriate actions.
• Define and assess process capability.

Lean Manufacturing:

• Understand concepts like Poka Yoke, SMED, and their application in assembly tooling and fixtures.
• Utilize 5S, Muda elimination, Kaizen, process flow, and spaghetti diagrams for production optimization.

Project transfer:

• Project Management skills.

BASIC QUALIFICATIONS

Education:

• Bachelor’s Degree or Diploma in Biomedical, Materials, Chemical, Electronics, Mechanical, or Industrial Engineering.

Experience:

• Degree holders: minimum 2 years of relevant experience in process/production engineering.
• Diploma holders or equivalent: minimum 8 years of relevant experience.
• Experience in the medical devices industry is preferable.
• Assist Project Manager in identifying and formulating technical tasks.
• Experience in coordinating, monitoring, and following up on technical tasks within projects.
• Familiarity with ISO13485 and GMP standards.
• Basic knowledge of SAP and MES is advantageous.
• Strong organizational, communication, and intercultural skills.

What we offer

• Encouragement to think and act entrepreneurially.
• Opportunity to work in global teams and projects.
• Professional development opportunities.