TSE Industries · 4 months ago
Manufacturing Engineer - Medical Device Manufacturer
Clearwater, FL
Full-time
Onsite
Mid Level
$70K/yr - $70K/yr
3+ years expTSE Industries Inc is a medical device manufacturer looking for a Manufacturing Engineer to manage and improve processes within the WHK medical device manufacturing department. The role involves ensuring compliance with ISO 13485, implementing new processes, managing BOMs and routings in the ERP system, and promoting safety and improvement initiatives.
Manufacturing
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
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
Qualification
Required
College degree (BS) required in an Engineering discipline
Minimum of 3 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 required
MS Office experience required; Outlook, Excel and PowerPoint
Project management skills and the ability to multitask
Good communication skills and the ability to get along well with others in a team environment
Ability to create part drawing, tool drawings and 3D models of new parts and assemblies
Ability to create work instructions, batch sheets and process standard work for existing and new operations
Preferred
Lean 6 Sigma training and certification highly desired
Company
TSE Industries
TSE is a certified manufacturer of custom molded, injected, and extruded rubber parts, plastic fabrication, Millathane, Thanecure and more.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase