Medical Device - Molding / Tooling Staff Engineer
We are looking for Medical Device - Molding/Tooling Staff Engineer for our client in Irvine, CA
Job Title: Medical Device - Molding/Tooling Staff Engineer
Job Location: Irvine, CA
Job Type: Contract – 12 Months / Contract to Hire / Direct Hire
“US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time.”
- Manages and controls the development and execution of assigned tooling programs and projects. Coordinates & support R&D personnel on part design as an advisor to plastic parts designers. Supports in molder/mold-maker selection and mold design, builds, releases and validates phases on new tool projects. Support Operations personnel in developing/optimizing, documenting and implementing the supplier molding processes used in producing the products assigned. Assists suppliers in mold repairs as an advisor to tool room personnel and is responsible overseeing suppliers’ mold preventive maintenance and repair programs and systems, as well as for mold spare programs.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Continuously assess organizational, equipment, operational and systemic needs to anticipate and resolve potential issues.
- Keep in house a Mold History File/Database for each assigned mold, as well as a Mold Drawings History Record/Database.
- Negotiate/design programs with suppliers that will ensure an adequate Preventive Maintenance and Spare Parts Program for each mold assigned.
- Maintain a thorough knowledge of the assigned products, processes and their component parts from functional points of view.
- Analyze plastic part quality problems as required and determine root cause traceable to mold conditions. Determine action plan and execute or support accordingly.
- Coordinate and support R&D on part design and quotation process for plastic parts.
- Keep abreast of changing technologies in tool design, build, and injection molding processing.
- Coordinate with Supply Chain to obtain outside tooling contractors and vendors quotations.
- Assist or coordinate the development of processes and molds/tooling necessary to produce new products Quality
- Basic understanding of GMP/QSR/ISO-13485
- Basic understanding of Corrective Action and Preventive Action Systems
- Make recommendations regarding facilities, equipment, personnel, procedures, and systems, to assure conformance to (supplier or internal) quality standards
- New Product Development
- Assist in the Design, development, or improvement of new or existing products or components
- Assist in planning, design, and development or test requirements and any special testing equipment to establish product specification
- Testing and Performance Protocols
- Mold Construction, Repairs, Troubleshooting
- DFM & Product design for molding.
- Plastics: materials / properties / design
- Molding: process capability / validations / troubleshooting
- Molds: selection, purchasing, managing, design reviews
- Perform Failure Mode and Root Cause Analysis and Investigation
- Must be a proactive problem solver possessing technical leadership and communication skills that lead and transition new technologies from the laboratory to the manufacturing floor.
- Work with technically complex and high impact projects where ingenuity and basic business understanding is required
- Use of Pro/E or SolidWorks for the design of basic fixtures
- Basic Understanding of Best Drawing Practices
- Basic Understanding of Geometric Dimensioning and Tolerance
- Familiar with Block Diagrams, schematics, isometric illustrations, orthographic illustrations, and 3D perspective illustrations
- B.S. in Engineeringdesired (Mechanical Engineering or Plastics Preferred)
- Six SigmaBlack Belt (a plus)
- Project Management Training
- 10+ years’ experience in Molding/Mold-making/Tooling management.
- 5+ years of experience in diverse technical, injection molding tooling, materials, manufacturing, quality, and product design.
- 10+ years in Medical Device or equivalent industry
- Experience in SPC/Statistical Analysis/DOE/Six Sigma tools
- Experience in Process Validations (IQ, OQ, PQ) and Test Method Validations (MSA)
Skills and Abilities
- Strong analytical skills
- Effective interpersonal skills
- Thorough understanding of Scientific Molding Principals
- Troubleshoot technical problems, determine and execute resolution plans
- Blueprint/Schematic reading and interpretation
- General knowledge of Injection Molding Machine configuration and operation
- Basic PC skills (MS-Office: Word/Excel/PowerPoint/Publisher/Project)
- Demonstrated ability to perform statistical analysis on pre-production and production data to establish capability indices (Cp, Cpk, Pp, Ppk)
- Understand and apply decoupled/scientific molding techniques in establishing new and existing processes, and general troubleshooting.
- Understand relationships/influences/interactions of machine parameters
- Understand tools and techniques to identify defects and causes
- Must be able to work with minimal supervision or guidance
- Demonstrate leadership and make decisions based on assessment of risk
- Able to work under pressure.
- Capable of managing multiple projects and priorities simultaneously.
- Must be able to work in a variety of environments (Laboratory, Office, Manufacturing Floor, Cleanroom, Molding Shops, Machine Shops and Tool Rooms)
- Ability to travel up to 25%