Process Engineer II - Exempt
LanceSoftIrvine, CA, United States3 days ago
Job type
- Full-time
Job descriptionProvide technical and sustaining engineering support in a manufacturing area. Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrate equipment and material capabilities to meet process module target specifications and technology target specifications. Review product development requirements for compatibility with processing methods to determine costs and schedules. Interact with product design and development personnel to ensure that processes and designs are compatible. Develop and conduct statistical analysis or recommend additions to document work. Lead the innovation, development and / or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. Develop manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensure processes and procedures are in compliance with regulations. Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for New Product Introductions through frequent interaction with R&D, Quality Engineering, and Operations using project management, design for manufacturability, and lean methodologies. Develop fixtures, tooling, and equipment. Develop process specifications which ensure user needs are met. Perform equipment and process characterizations and qualifications (IQ / OQ / PQ). Manage required builds for new product development in a pilot or production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, supervising builds, and troubleshooting assembly issues. Comply with applicable FDA and international regulatory laws / standards. Perform other duties as assigned or required. Bachelor's degree in Engineering (preferably Mechanical, Electrical, or Biomedical) 2 years of experience developing products and / or manufacturing processes in medical device industry Knowledge of SolidWorks and engineering statistics Good verbal and written communication skills Computer literate; word processing, spreadsheets Knowledge of processing materials associated with medical devices such as Polymers (nylons, polyethylene, polypropylene, PEEK, PTFE, FEP, etc.), and Metals (nitinol, platinum, stainless steel, etc.). Hands-on experience with processes associated with medical manufacturing such as shrinking (reflow), laser bonding, laser welding, thermal bonding, adhesive bonding, braiding, coil winding, hydrophilic coating, plasma treatment, cleaning processes, crimping, heat setting, electropolishing, swagging, etc. Experience with development and qualification of fixtures / tooling / equipment (IQ / OQ / PQ, support, design). Experience working with outside OEM Suppliers in component development, and selection of equipment and processes. Experience being on project teams tasked with new product development and successful transfer into manufacturing. Knowledge of design and process FMECA, process validation, and process control. Knowledge of design for manufacturability and lean methodologies.
HM's Top Needs :
- Previous medical device experience
- Hands-on experience in manufacturing (preferably medical device)
- Process validation experience
Education Required : Science / Engineering Degree : E2 (BS, MS)
Years' Experience Required : E2 (min. 1-2 yrs)
Work Schedule : 40 hours a week
Work Location : Irvine (two different buildings)
Onsite Requirement : Onsite 3-5 days / week
Responsibilities
Responsibilities may include the following and other duties may be assigned :
Primary Responsibilities
Minimum Qualifications
Preferred Qualifications
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Engineer Ii • Irvine, CA, United States
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