Project Engineer (Medical Devices)
Job Opportunity at Coyote Technical Executive Sourcing, LLC

Posted on Feb 10

Location: Pinnelas Park, FL
Job Type: Full Time
Job ID: W4152456

Project Engineer

Responsible for the development of new products and manufacturing processes through management of the Advanced Product Quality Planning (APQP) process, resulting in delivery of robust products, tooling and processes to the manufacturing department and end-user customers.

ESSENTIAL JOB FUNCTIONS include the following. Other duties may be assigned.
  • Manage the APQP and New Tool Build process for new programs
  • Train production personnel and work with Process Engineering to transfer new programs to production
  • Interact with customers and other technical personnel to assist with the development and design of the product and processes to improve functionality and manufacturability
  • Identify and select equipment and technologies to be used for new products and processes
  • Develop preventative maintenance plans as related to new tooling and equipment.
  • Conduct FMEA, DOE, SPC analysis and use other quality tools to fulfill customer requirements and manufacturing initiatives
  • Provide technical guidance, direction and support for manufacturing
  • Provide input to the production controls system and design controls activities
  • Quality initiatives as they relate to the customer, corporate objectives, quality planning, the quality policy, process improvement and new business goals and objectives. Communicate with customers, suppliers and other resources in order to achieve these objectives
  • Participate in research and development activities in terms of process implementation and validation of processes / products, tooling process improvement and business metrics
  • Provide input for new product equipment selection, installation and maintenance
  • Write detailed work instruction-level documents for manufacturing operations and related areas. Summarily train personnel in these instructions and other technical process controls
  • Conduct engineering studies and analyze data
  • Map work flow(s) and develop process control plans
  • Direct the validation activities for new tools and processes
  • Develop and submit validation packages for customer approval of new parts, design modifications and / or process changes
  • Develop and evaluate inspection methods and measurement capabilities
  • Evaluate process stability and capability
  • Interact with equipment and tooling vendors for new products or design/process changes.
  • Conduct VAVE (Value Engineering) activities.
  • Manage new tool and equipment builds.
  • Maintain project schedule with tasks and deliverables.
  • Lead or direct Tooling Engineering with the Development of New Tooling and Fixtures.
  • Bachelor's degree in Engineering and at least five years of related experience. Must have experience in medical device and experience in the following areas: product, fixture gauge design and new project implementation; Solidworks; data analysis using statistical tools.
  • Demonstrated ability to read, analyze, and interpret common scientific and technical journals, to respond to common inquiries or complaints from customers, regulatory agencies, or customers; to write procedures, protocols, engineering studies and reports that conform to prescribed style and format; and to effectively present information to top management, and/or boards of directors.
  • Demonstrated ability to apply advanced mathematical and statistical concepts such as capability studies and failure and reliability; interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Evidence of successful project management with multiple team members, customers involving equipment and tooling.
  • Knowledge of Microsoft Project, Office, Outlook, Word and MiniTab Statistical software.

No sponsorship visa (H1-B, etc) candidates at this time, sorry.
Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:
Phil Montoya
Director of Sourcing
3735 SW 8th Street, Suite 205
Miami, FL 33134
P: 832-266-1610
Fax: 305-520-0138
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