Engineer II - Product Developmen/Design

Pursuant to section 656.10 of Title 20 of the Code of Federal Regulations (20 C.F.R. * 656.10), you are hereby notified that an Application for Permanent Employment Certification is being filed for the following position:

CPE 1 LLC seeks Product Development/Design Engineer in Pembroke Pines, FL.

Duties: Initiates, directs and manages the design, and development of new products and processes from concept to commercial manufacturing. Works closely with other departments to coordinate design engineering activities. Reviews, initiates or approves engineering drawings, layouts, changes orders and specifications. Plans process flow, evaluates process capability, modifies tooling, builds tooling, and designs tooling. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part o f a major project. Develops and /or reviews test procedures and plans prior to implementation, as well as conduct failure analysis and inspection on products, processes and materials. Evaluates, selects, and applies standard engineering techniques and procedures while using judgment when making minor adaptations and modifications. Devises new approaches to problems encountered. Prepares all necessary paperwork and documentation for all projects undertaken.

Requires a Bachelor's degree in Engineering Management, Systems Engineering, or related (or its equivalent) plus 3 years of experience. Alternatively, requires a Master's degree in Engineering Management, Systems Engineering, or related (or its equivalent) plus 2 years of experience. Requires 2 years of experience with the following: Design, plan, execution, and analysis involving design verification and design validation studies with physicians on devices that have been successfully brought to market; Utilizing root cause analysis techniques including Fault Tree Analysis, Fishbone, or DMAIC to resolve technical issues, sample size/resource constraints, or other engineering hurdles; Communicating with upper management, stakeholders, and external customers by leading a design review or similar exercise; Working on multiple products using Design control per FDA 21 CFR Part 820.30 and ISO 13485 across the full product development lifecycle from voice of customer through design input, design verification and validation, submission and clearance, process validation, to commercial release; Neurovascular anatomy and physiology, and experience applying engineering principles to determine vascular product requirements; Providing a timeline and cost estimate of work toward a quote, engage with customer including status updates and resolving issues, and approach the customer regarding the quotation of out-of-scope work; Utilizing risk analysis tools such as Failure Mode and Effects Analyses and Risk Management Reports.

40 hours/week, $94,286 per year. Must also have authority to work permanently in the U.S. Applicants who are interested in this position may apply https://www.jobpostingtoday.com/ Ref # R32929

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer:

U.S. Department of Labor

Employment and Training Administration

Office of Foreign Labor Certification

200 Constitution Avenue NW

Room N-5311

Washington, DC 20210

Phone: (404) 893-0101

Fax: (404) 893-4644