Process Development Engineer

3 weeks ago


Miami Lakes, United States DemeTECH Corp Full time
Job DescriptionJob Description

Responsibilities:

 

  • Write engineering justification memos.

  • Analyze Design problems or deficiencies and develop solutions to resolve them.

  • Aspects of the product design and development of a project with a focus on innovative implantable medical devices that address the customer needs for a complete procedural solution.

  • Support project activities through the management of budgets, resources, timelines, and deliverables.

  • Plan, coordinate, and direct the application of Quality Engineering practices for New Product Development (NPD) and Design Transfer teams on a project basis from concept to commercialization.

  • Work within a cross-functional project team through all phases of the product development process, planning and executing projects through the product launch.

  • Work closely with members of the project core team (marketing, manufacturing, quality, simulated use testing, etc.), and support the development of product and process validation plans and testing

  • Manage the quality of the technical team's implementation of incoming inspection, calibration, and inventory control systems.

  • Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed.

  • Involved in test method development and testing of the proposed design.

  • Work with manufacturing engineering and suppliers to optimize designs for manufacturability and produce prototypes.

  • Develop an expert knowledge of our product lines and detailed knowledge of various anatomies and pathologies.

 

Education: A bachelor's degree is required; preferably in Mechanical, Biomedical, Electrical, or Automation Engineering discipline.

Communication skills: Good written and oral English communication skills.

Technical Proficiencies: Organizational Skills, Presentation Skills, Project Management, Results Driven, Mathematical Skills, Technical Capacity, Thoroughness, Time Management.

Judgment and Decision Making: Capable of working independently on assigned project activities in a cross functional team environment. Must possess a good understanding of engineering fundamentals.

Experience: Experienced in Medical Device product development process. Good Understanding of Design history file (DHF) / Technical Documentation. Good understanding of ISO Management principles. Experience with prototype design / fixture design and performing functional testing.

Experience with Design V&V, writing protocols, Testing, results analysis, application of statistical techniques, Report preparation. Experience in the ECR / ECO process and also proficient with PLM system (e.g., Agile / windchill or any similar PLM tool). Must be proficient in Fusion 360 / SolidWorks. Experience in product design, process development, automation, PLC, HMI, pneumatics, Process Control, device testing or prototyping- Capable of applying standard statistical practices and techniques in specific situations, and to adjust and correlate data and recognize discrepancies in results.

Company DescriptionDemeTECH Corporation is a leading manufacturer of medical devices located in Miami Lakes, FL.Company DescriptionDemeTECH Corporation is a leading manufacturer of medical devices located in Miami Lakes, FL.
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