WHK Manufacturing Engineer

TSE Industries Inc•Clearwater, FL

16h•Onsite

About The Position

The WHK Manufacturing Engineer will manage and improve all processes within the WHK medical device manufacturing department. This role involves working closely with the Quality department to ensure all systems comply with ISO 13485 requirements. Key responsibilities include implementing new processes, assisting with the onboarding of new business, and setting up and managing Bills of Material (BOMs) and Routings in the ERP system for new part introduction and process changes. The engineer is also expected to promote safety, housekeeping, and area improvement initiatives. Specific duties include writing and executing IQ/OQ/PQ validation protocols, leading root cause analysis for customer complaints and process waste, and implementing corrective actions. The position requires the ability to assist in developing machine specifications, modifying equipment layouts, identifying potential equipment upgrades, and completing cost analysis for capital requests. A strong understanding of Continuous Improvement tools and Lean 6 Sigma concepts, including guiding Kaizen events, is essential. Project management skills are critical for multitasking and meeting deadlines. The engineer will interact with customers, guide new products from inception to production, and work within a Clean Room environment, possessing knowledge of its practices and change management. Good communication skills and teamwork are a must. Additional tasks include creating part and tool drawings, 3D models, developing and monitoring key production KPIs, creating work instructions and standard work, and assisting with equipment calibration and maintenance programs. The role also involves continuously seeking opportunities to improve safety, quality, and productivity in established production methods and assisting with special projects.

Requirements

Possess previous experience in medical device manufacturing.
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.
Ability to get along well with others in a team environment.
Complete and maintain General Safety Orientation training.
Complete and maintain Hearing Protection Training.
College degree (BS) in an Engineering discipline.
Minimum of 3-5 years manufacturing experience in an ISO 13485 regulated environment.
Experience working in a Clean Room environment.
Prior hands-on experience with injection molding and extrusion machinery.
MS Office experience (Outlook, Excel, and PowerPoint).
Ability to express thoughts clearly, both verbally and in written context.
Ability to write reports and business correspondence.
Ability to communicate effectively.
Strong knowledge in working with the MS Office Suite.
An understanding of all basic mathematical skills.
An understanding of trigonometry and angular relationships is necessary in order to understand and interpret blueprints.
Familiarity with the different processes required to process materials through a manufacturing environment.

Nice To Haves

Lean 6 Sigma training and certification

Responsibilities

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.
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.
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.
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 is 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.
Revisit established production methods to seek out opportunities for improvement in safety, quality, and productivity.
Assist with special projects as needed.
Teamwork with co-workers in the same department, every other employee, department and division.