Process Engineer II - Exempt

LanceSoft Inc

Irvine, CA

Apply

JOB DETAILS

JOB TYPE

Full-time

SKILLS

Biomedicine, Build Management, Communication Skills, Component Selection, Computer Skills, Develop Methodologies, Electricity, Equipment Selection, FDA Requirements, Identify Issues, International Law, Lean Manufacturing, Machine Tool, Manufacturing, Manufacturing Assembly, Manufacturing Design, Manufacturing Methods, Manufacturing Operations, Manufacturing/Industrial Processes, Mechanical Engineering, Medical Equipment, OEM (Original Equipment Manufacturer), Operations Management, Plasma, Polymers, Presentation/Verbal Skills, Process Control Engineering, Process Development, Process Engineering, Process Validation, Product Design, Product Development, Product Reviews, Product/Service Launch, Production Planning, Project/Program Management, Quality Engineering, Quality Metrics, Regulatory Compliance, Requirements Management, Research & Development (R&D), SolidWorks, Spreadsheets, Statistical Process Control, Statistics, Technical Support, Welding, Word Processing, Writing Skills

LOCATION

Irvine, CA

POSTED

30+ days ago

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: Provide 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. Primary 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. Minimum Qualifications 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 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 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.

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

Resume Resources

Free Resume Templates Free Resume Builder