Process Engineer (Medical Device)

Key Responsibilities:

• Review and update product routing and structure related to production processes.
• Analyze unplanned downtime and propose improvement plans for equipment, jigs, fixtures, and tooling.
• Coordinate with vendors on process equipment maintenance or upgrades, including on-site support when required.
• Collaborate with NPI teams on new process development and qualification of new production equipment or tooling.
• Lead investigations into production process non-conformances and drive corrective actions.
• Lead troubleshooting, testing, and improvement initiatives for production processes.
• Implement and hand over process improvements to production teams.
• Maintain documentation and records related to equipment and processes in line with QMS requirements.
• Support audit preparations and assist during customer or regulatory site visits.

Key Requirements:

• Bachelor's Degree in Engineering or Science (or equivalent).
• Minimum 2 years of relevant experience, preferably in a manufacturing or medical device environment.
• Familiar with ISO 13485 and GMP standards (advantageous).
• Strong problem-solving and analytical skills with the ability to work independently or in a team.
• Proficient in Microsoft Office applications.