Senior Process Engineer

Location: Onsite; Irvine, CA

Pay Rate: $70-$80 /hr. on W2 with benefits

1 Year Contract with extension or conversion to an FTE

Summary

We are a rapidly growing, global medical device manufacturer that is committed to developing innovative endovascular technologies for neurological applications. Creative, competent people with a passion for enhancing healthcare around the globe have driven our success. Here’s where you come in!

We are seeking a hands-on Sr. Process Development Engineer to work closely with R&D, Operations and Quality in the development of new processes necessary to produce Delivery Systems/Stents/Other Medical Devices for a lean manufacturing environment. The ideal candidate will have prior experience working in the medical device industry developing new manufacturing processes, implementing and qualifying production equipment and methods, managing development builds, generating testing protocols and reports, and working with minimal direction for New Product Introductions.

Responsibilities

• 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.

Required Qualifications

• Bachelor’s degree in Engineering (preferably Mechanical, Electrical, or Biomedical)
• 4+ 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

Preferred Qualifications

• 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 manufacturing line layout, capacity analysis, and line balancing.
• Process background (development, capability, optimization, validation) within a regulated industry.
• Proficient 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.
• Experience with design and process FMECA, process validation, and process control.
• Knowledge of design for manufacturability and lean methodologies.