Senior Manufacturing Engineer – Global Transfers & QA

Intuitive

Penang

On-site

MYR 180,000 - 300,000

Full time

5 days ago
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Job summary

Intuitive Surgical in Penang seeks a Sr. Manufacturing Engineer to lead line transfers of instruments and accessories, drive reliability and cost improvements, and mentor cross-functional teams in a medical device setting.

The role supports manufacturing, problem solving, and documentation across mechanical, electromechanical, and automation disciplines, with extensive collaboration and global plant transfers.

Qualifications

  • BS in Engineering; MS in Engineering preferred.
  • 8+ years mechanical/manufacturing engineering experience in high-volume manufacturing.
  • Experience leading validation/verification in regulated environments.
  • Strong analytical and problem-solving skills.
  • Experience with pFMEA, tolerance analysis, DoE, SPC, GR&R, and Cpk.
  • Good cross-functional communication across multiple disciplines.
  • Experience in ISO 13485/ISO 9001 medical device contexts preferred.
  • Proficient in Microsoft Office; bilingual English.

Responsibilities

  • Lead transfers of production lines from global plants to Penang site.
  • Validate and qualify manufacturing equipment and processes (DQ/IQ/OQ/PQ/PPQ).
  • Provide day-to-day line support for engineering activities in Penang.
  • Address root causes and implement corrective actions for quality issues.
  • Drive continuous improvement: yield, cycle time, reliability, cost reduction.
  • Contribute DFA/DFM input to standardize products and processes.
  • Create and approve manufacturing/engineering docs (WIs, SOPs, protocols).
  • Assist with supplier quality and ECOs; support audits and CAPA closures.
  • Travel to Intuitive plants globally as needed (up to 50% first year).

Skills

Manufacturing engineering
Problem solving
Data analysis
Communication
ISO 13485
MS Office
Solid modeling
English (Bilingual)

Education

BS in Engineering
MS in Engineering preferred

Tools

Solid modeling

Job description

Intuitive Surgical in Penang seeks a Sr. Manufacturing Engineer to lead line transfers of instruments and accessories, drive reliability and cost improvements, and mentor cross-functional teams in a medical device setting.

The role supports manufacturing, problem solving, and documentation across mechanical, electromechanical, and automation disciplines, with extensive collaboration and global plant transfers.

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