Description:
SUMMARY
Work with Engineering Manager to establish, validate, and improve all manufacturing processes. Manage New Product Introductions and related Engineering Change Orders. Implement new processes and assist with onboarding all new business. Create drawings and 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned
· Support all manufacturing processes and address problems by troubleshooting and problem solving.
· 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.
· Create part drawing, tool drawings, and 3D models of new parts and assemblies.
· Create work instructions and train operators for existing and new operations.
· Project Manage new product development initiatives through the Engineering Change Order process
· Lead, participate, and assist in root cause analysis of customer complaints and process waste issues with accountability for corrective action implementation.
· Interact with customers concerning inquiries. Take new products from inception to prototype and into production.
· 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.
· Must possess project management skills and the ability to multitask. Attention to meeting deadlines and customer commitments is critical.
· 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.
· 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 is essential for TSE's continued success, so Teamwork is an essential function of every employee's job. Teamwork drives positive results every day. Teamwork promotes positive customer relations and results in exceeding the expectations of our customers. Teamwork benefits every employee since it grows our business and increases our sales. With Teamwork, we all succeed. Without it, we all suffer. Teamwork with co-workers in the same department is just the beginning. Teamwork with every other employee, department and division is the Teamwork that is required to succeed. WE ARE TSE.
Requirements:
SAFETY TRAINING To perform this job successfully, an individual must complete and maintain the following Safety Training requirements.
General Safety Orientation Hearing Protection Training
QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND/OR EXPERIENCE
· College degree (BS) required in an Engineering discipline.
· Must have minimum of 3-5 years manufacturing experience in an ISO 13485 or similar regulated environment.
· Must have experience working in a Clean Room or controlled environment.
· Must have above-average project management skills. A project management certification is a plus.
· Prior hands-on experience with injection molding and extrusion machinery is a plus.
· Must be proficient in Solidworks and MS Office – Outlook, Excel, and PowerPoint. Lean 6 Sigma training and certification highly desired.
LANGUAGE SKILLS
Must possess the ability to express thoughts clearly, both verbally and in written context. Ability to write reports and business correspondence. Ability to communicate effectively. Must have strong knowledge in working with the MS Office Suite.
MATHEMATICAL SKILLS
An understanding of all basic mathematical skills. An understanding of trigonometry and angular relationships is necessary in order to understand and interpret blueprints.
REASONING ABILITY
Should be familiar with the different processes required to process materials through a manufacturing environment. This knowledge would help the individual to be able to improve processing points throughout the manufacturing operations.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use their hands, fingers, and arms. Employee is regularly required to talk and/or hear. Employee must be able to lift and/or move up to 50 lbs. The employee is expected to use a team lift approach or the appropriate equipment for items weighting >50 lbs. Specific vision abilities required include close vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. The noise level in the work environment is usually loud
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