WHK Manufacturing Engineer

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Work with Quality to ensure that all processes are in compliance with ISO 13485 requirements.
• Write IQ/OQ/PQ validation protocols, execute validation protocols for new equipment and process changes, and write summary reports for management review and approval of all validations.
• Lead, participate, and assist in root cause analysis of customer complaints and process waste issues with accountability for corrective action implementation.
• Absorb and modify machine specifications for new equipment and develop and modify equipment layout to generate process flow.
• Identify potential equipment upgrades and/or new equipment requirements and complete cost analysis and justification for any capital request.
• Promote safety, housekeeping, and area improvement initiatives.

Requirements

• College degree (BS) required in an Engineering discipline.
• Minimum of 3-5 years manufacturing experience in an ISO 13485 regulated environment.
• Prior hands-on experience with injection molding and extrusion machinery required.
• MS Office experience required – Outlook, Excel, and PowerPoint.
• Prior Lean 6 Sigma training and certification highly desired.
• Strong knowledge in working with the MS Office Suite.
• An understanding of all basic mathematical skills and trigonometry and angular relationships.