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Manufacturing Process Engineer
2 months ago
POSITION OVERVIEW
Collaborate with the Engineering Manager to develop, validate, and enhance all manufacturing workflows. Oversee New Product Introductions and associated Engineering Change Orders. Facilitate the implementation of new processes and support the onboarding of all new business initiatives. Generate technical drawings and manage all Bill of Materials (BOMs) and Routings within the ERP system for new part introductions and any modifications to existing processes. Advocate for safety, cleanliness, and continuous improvement initiatives within the workspace.
KEY RESPONSIBILITIES include, but are not limited to:
- Provide support for all manufacturing operations and resolve issues through effective troubleshooting and problem-solving techniques.
- Collaborate with the Quality team to ensure compliance with ISO 13485 standards across all processes.
- Develop and execute IQ/OQ/PQ validation protocols for new equipment and process modifications, and prepare summary reports for management review and approval.
- Create detailed part drawings, tooling designs, and 3D models for new components and assemblies.
- Draft work instructions and train operators on both existing and new processes.
- Manage new product development projects through the Engineering Change Order workflow.
- Lead and participate in root cause analysis for customer complaints and process inefficiencies, ensuring accountability for corrective actions.
- Engage with customers regarding inquiries and oversee the transition of new products from concept to prototype and into full-scale production.
- Identify potential equipment upgrades or new equipment needs, including conducting cost analyses and justifications for capital requests.
- Demonstrate knowledge of Continuous Improvement methodologies and Lean Six Sigma principles.
- Exhibit strong project management capabilities and the ability to handle multiple tasks simultaneously, with a keen focus on meeting deadlines and fulfilling customer commitments.
- Work effectively in a Clean Room environment, understanding the best practices and change management protocols necessary for such settings.
- Maintain excellent communication skills and foster positive relationships within a team-oriented environment.
- Assist in coordinating the equipment calibration program and managing preventive and predictive maintenance schedules.
- Reassess established production techniques to uncover opportunities for enhancements in safety, quality, and efficiency.
- Support special projects as required.
Teamwork is vital for TSE Industries' ongoing success. It drives positive outcomes daily, fosters strong customer relationships, and contributes to exceeding customer expectations. Collaboration among all employees, departments, and divisions is essential for achieving our goals. Together, we thrive; without teamwork, we face challenges.
SAFETY TRAINING
To successfully perform this role, completion and maintenance of the following safety training requirements are necessary:
- General Safety Orientation
- Hearing Protection Training
QUALIFICATIONS
To excel in this position, candidates must demonstrate the following:
EDUCATION AND EXPERIENCE
- A Bachelor’s degree in an Engineering discipline is required.
- A minimum of 3-5 years of manufacturing experience in an ISO 13485 or similar regulated environment is essential.
- Experience in a Clean Room or controlled environment is necessary.
- Strong project management skills are a must; certification in project management is advantageous.
- Hands-on experience with injection molding and extrusion machinery is preferred.
- Proficiency in SolidWorks and MS Office Suite (Outlook, Excel, PowerPoint) is required. Lean Six Sigma training and certification are highly desirable.
LANGUAGE SKILLS
- Ability to articulate thoughts clearly in both verbal and written forms. Proficient in writing reports and business correspondence.
MATHEMATICAL SKILLS
- Understanding of basic mathematical concepts, including trigonometry and angular relationships, is necessary for interpreting blueprints.
REASONING ABILITY
- Familiarity with various processes required for material processing in a manufacturing environment is essential for improving operational efficiency.
PHYSICAL DEMANDS
- The physical demands outlined here represent those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities.
- Regularly required to use hands, fingers, and arms; must be able to lift and/or move up to 50 lbs, utilizing team lift approaches or appropriate equipment for heavier items.
WORK ENVIRONMENT
- The characteristics of the work environment described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities.
- While performing duties, employees may be exposed to moving mechanical parts, fumes, airborne particles, and toxic or caustic chemicals. The noise level in the work environment is typically loud.
