Lead Process Engineer, Medical Device Automation

RRecruiter

Singapore

On-site

SGD 120,000 - 180,000

Full time

3 days ago
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Job summary

RRecruiter is seeking aSenior Process Engineer to lead the Process Engineering team in Singapore. You will drive automation initiatives, oversee equipment maintenance, and champion process validation to maximize uptime and product quality in a regulated environment.

Ideal candidates bring extensive hands-on automation experience within medical devices or pharma, with strong skills in robotics, fixture design, and regulatory familiarity (FDA/EU MDR/ISO standards).

Qualifications

  • Bachelor’s degree in Mechanical/ Electrical Engineering or Materials Science.
  • 5–10 years hands-on automation and automated assembly experience in medical device/pharma.
  • Experience in automation systems, robotics, tooling and fixture design/development.
  • Led automation projects from concept to implementation including qualification and validation.
  • Working knowledge of cGMP manufacturing environments.
  • Strong knowledge of assembly process optimization, manufacturing automation, equipment reliability and process capability.
  • Familiarity with FDA regulations, EU MDR 2017/745, ISO 13485 and ISO 14971 is an advantage.

Responsibilities

  • Lead the Process Engineering team to support production and value-stream objectives.
  • Drive initiatives to maximize machine uptime, equipment reliability, process capability, yield, output, quality and OEE.
  • Lead automation, equipment upgrade, and assembly process improvement projects.
  • Oversee equipment maintenance, preventive maintenance, calibration, and risk assessment activities.
  • Lead equipment/process validation and provide required engineering resources and support.
  • Drive continuous improvement and productivity initiatives while minimizing production disruptions.
  • Manage engineering resources, budgets, and capital expenditure (CAPEX).
  • Collaborate with cross-functional teams, suppliers, subcontractors, other plants, and external parties to improve equipment and process effectiveness.
  • Ensure compliance with quality, safety, environmental, and company policies through effective communication, training, and implementation.

Skills

Automation systems
Robotics
Fixture design
Process validation
cGMP knowledge
Assembly optimization
Equipment reliability
CAPEX management

Education

Bachelor’s degree in Engineering

Job description

RRecruiter is seeking aSenior Process Engineer to lead the Process Engineering team in Singapore. You will drive automation initiatives, oversee equipment maintenance, and champion process validation to maximize uptime and product quality in a regulated environment.

Ideal candidates bring extensive hands-on automation experience within medical devices or pharma, with strong skills in robotics, fixture design, and regulatory familiarity (FDA/EU MDR/ISO standards).

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