Job Details

DeRoyal is an Equal Opportunity/Affirmative Action employer. Interviewing and hiring practices at DeRoyal do not discriminate on the basis of race, color, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, veteran status or any other category protected by law.

6103 - 2717 Plastics Manufacturing Engineer

Are you passionate about engineering innovation in plastics manufacturing? Join our dynamic team at DeRoyal, where your expertise will drive process optimization, compliance, and product excellence in a fast-paced, collaborative environment. We're looking for a skilled Plastics Manufacturing Engineer to join our Royal Precision Plastics facility in Powell, TN.

Some Key Responsibilities Include:

Design, develop, and optimize manufacturing processes for production.

Provides support for development of manufacturing specifications and procedures.

Initiates and monitors the entire mold procurement process. Ensure that ISO 13485 and FDA GMP Design Control requirements are adhered to per the Quality Manual.

Conduct operations in accordance with safety requirements.

Collaborate with cross-functional teams including R&D, Quality Assurance, and Regulatory Affairs to ensure product manufacturability and compliance.

Implement methodologies to improve efficiency and reduce waste.

Troubleshoot and fix long-term machine issues.

Develop and maintain process documentation including work instructions, validation protocols, and standard operating procedures (SOPs).

Assist with equipment selection, installation, and qualification activities.

Read and understand blueprints and machine specifications.

Retrieves and modifies detailed component and product drawings on CAD (Computer Aided Design).

Support root cause analysis and corrective/preventive actions (CAPA) for production issues.

Analyze production data to identify trends and recommend improvements.

Train production staff on new processes and equipment.

Takes leadership role on technical project teams.

Works with minimum supervision.

PREFERRED QUALIFICATIONS:

Strong knowledge of GMP, FDA regulations, and ISO 13485.

Proficiency in CAD software and manufacturing simulation tools.

Experience with process validation, statistical analysis, and risk management tools (e.g., FMEA).

Excellent problem-solving, communication, and project management skills.

Experience with automation and robotics in manufacturing.

Familiarity with ERP systems and MES platforms.

General knowledge of injection molding processes.

EDUCATION AND/OR EXPERIENCE:

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, or related field. Minimum of 3 years of experience in a manufacturing engineering role, preferably in the medical device and/or plastics industry.

Ready to make an impact? Apply now and join a team that values innovation and collaboration.