Manufacturing Engineer - Medical Device Manufacturer

(Starting Wage, $80,000 + per year DOE)

SUMMARY – Manage and improve all processes with the WHK medical device manufacturing department. Work with Quality to ensure all systems are in compliance with ISO 13485. Implement new processes and assist with onboarding of all new business. Set-up and manage all BOM’s and Routings in ERP system for new part introduction and for any process changes. Promote safety, housekeeping and area improvement initiatives.

REQUIREMENTS/EDUCATION and/or EXPERIENCE – College degree (BS) required in an Engineering discipline. Must have minimum of 3 years manufacturing experience in an ISO 13485 regulated environment.

• Must have experience working in a Clean Room environment.
• Prior hands-on experience with injection molding and extrusion machinery required.
• Lean 6 Sigma training and certification highly desired.
• MS Office experience required; Outlook, Excel and PowerPoint.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.

• 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.

• Ability to assist with developing machine specifications for new equipment and ability to develop and modify equipment layout to generate process flow.

• Ability to identify potential equipment upgrades and/or new equipment requirements and the ability to complete cost analysis and justification for any capital request.

• Understanding of Continuous Improvement tools and Lean 6 Sigma concepts and the ability to guide Kaizen events and improvement efforts.

• Must possess project management skills and the ability to multitask. Attention to meeting deadlines and customer commitments is critical.

• Interact with customers concerning inquiries. Take new products from inception to prototype and into production.

• Ability to work within a Clean Room environment and possess working knowledge of acceptable practices and management of change in such an environment.

• Good communication skills and the ability to get along well with others in a team environment a must.

• Ability to create part drawing, tool drawings and 3D models of new parts and assemblies

• Develop, monitor and report key production KPI’s during daily production meetings.

• Ability to create work instructions, batch sheets and process standard work for existing and new operations.

• Assist with coordination of equipment calibration program as well as management of equipment Preventive and Predictive maintenance programs

• Re-visit established production methods to seek out opportunities for improvement in safety, quality and productivity.

• Assist with special projects as needed

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