Mechanical Engineer– Injection Molding
- Reno, NV
- Permanent
- Full-time
- Production Line Setup and Support:
- Design/modify precision medical molding & inspection lines and equipment
- Provides expertise in process parameter development for optimal equipment run conditionals for high and stable yield
- Manage start-up, debug, and commission of new manufacturing processes
- Equipment life cycle management including upgrades, replacement, and decommissioning
- Drive continuous improvement activities again measurable targets in quality, delivery, and cost
- Provide technical support/troubleshooting to injection molding operations
- Manage and execute new mold validations through our internal processes including writing and executing IQ/OQ/PQ protocols to qualify new equipment and processes
- Support product life cycle management including product design changes, material changes, Supplier Notice of Change (SNC) assessments, specification changes, etc.
- Project Management:
- Manage capital projects both directly and through coordinating engineers
- Manage multiple projects with minimal supervision
- Prepare estimates for various tasks and projects
- Technical Documentation and Regulatory Compliance:
- Demonstrate proactive communication and problem solving
- Responsible for always adhering to FDA regulations
- Adhering to and maintaining all department Standard Operating Procedures (SOPs), forms, and logbooks
- Generate technical documents, reports, equipment specifications, and interpret technical drawings/schematics
- Establish, maintain, and ensure compliance to process Control Plan per PFMEA
- Required Qualifications:
- Detailed understanding of plastics molding-related process variables and their impact on throughput, quality, and yield rate
- Knowledge of and subject matter expertise of Scientific Molding/De-coupled Molding concepts is required
- Strong knowledge on process development and troubleshooting (Scientific molding principles)
- Programming/troubleshooting experience with automation controls, automated assembly, control systems, PLC’s, HMI’s, Servo’s, and vision inspection systems is a plus
- Capable of writing detailed technical specifications to ensure process and product capability, set-up, and calibration procedures, and support the development and implementation of equipment standards to insure ease of operation, safety, and maintainability
- Strong project Management skills and experience
- Strong to expert-level 3D CAD skills, including advanced surfacing and large assemblies
- Bachelor’s degree in engineering Required (Mechanical, Industrial, Electrical, Chemical, or Polymer Science degrees are preferred)
- 10+ years of direct hands-on experience with injection molding, including injection molding process development, machine selection & setup and mold design and/or mold construction
- Experience deploying Continuous Flow Manufacturing, lean principles, and statistic control
- Preferred Qualifications
- FDA manufacturing preferred
- Experience with Creo a plus
- Six Sigma Certification or industry standard equivalent is a plus
- Experience with Microsoft Project software a plus
- Diverse portfolio of exciting and innovative design projects
- Tremendous opportunities for professional growth and advancement
- Commitment to sustainable design
- Competitive Compensation
- Excellent Benefit Package (medical, dental, vision insurance, paid time off, disability insurance, 401k, tuition reimbursement and much more)
- Solid Stable Company
- Drug free workplace