Job Title:  Product Development Engineer

The ideal candidate is technically strong, organized, and comfortable working cross-functionally with Sales, Marketing, Manufacturing, and customers to deliver high-quality products that meet customer needs, cost targets, and schedule commitments.

Responsibilities

• Lead multiple transfers and or new product development projects simultaneously from concept through production release.
• Translate Voice of Customer (VOC), market requirements, and business objectives into robust product designs.
• Collaborate with Sales and CAS to define product requirements and align new developments with the company’s technology roadmap.
• Develop product concepts, detailed designs, and prototypes using sound engineering principles.
• Prepare project cost estimates, schedules, and technical risk assessments.
• Actively control Material and Labor variance against standards.
• Coordinate and, when needed, support prototype fabrication and process development activities.
• Fixtures and Tooling Manufacturing, contact Local and Regional Suppliers
• Automate current Fixtures and Tooling
• Plan and execute design verification and validation testing, IQ’s, OQ’s, PQ,s FAI & Process Characterization; identify issues and drive resolution.
• Evaluate materials, manufacturing processes, tolerances, and design tradeoffs to optimize performance, reliability, and manufacturability by use of SPC tools.
• Create and release engineering documentation including specifications, BOM’s, Visual Aids, test plans, capacity analysis and building instructions.
• Closely monitor yields and take actions when needed by identifying top offenders.
• Partner with Planning, Production and Quality to support smooth transition of new products into production mode.
• Monitor project progress, manage priorities across multiple active programs, and communicate status, risks, and mitigation plans to stakeholders.
• Apply sound engineering judgment to determine when a project has met technical, customer, and business objectives and is ready for formal project closure.
• Support continuous improvement initiatives and evaluate existing products for performance or manufacturability enhancements 

Requirements 

• Bachelor’s degree in Mechanical Engineering, Materials Science, or a related engineering discipline (or equivalent experience).
• 3+ years of experience in product design, development, and manufacturing environments.
• Demonstrated ability to manage multiple engineering projects at the same time in a structured development environment.
• Experience with one or more of the following manufacturing technologies:
  •    Crimping processes
  •    Iron Soldering Processes
  •    Cutting and stripping processes
  •    Molding processes
  •    IPC 620, 610 & J-STD-001
  •    Laser printing
• Knowledge on ISO 13485 and FDA regulations.
• Demonstrate strong understanding of Auto-Cad, SolidWorks, Excel, Word and PowerPoint.
• Strong written and verbal communication skills with the ability to interface with customers and cross-functional teams.
• Evaluate and develop technicians performance level.

The PDE Engineer position must have :

• Experience working in high-reliability, regulated, or custom-engineered product environments.
• Hands-on prototyping or manufacturing support experience.
• Familiarity with cost modeling, PFMEA, and design for manufacturability principles.
• Experience supporting customer validation and qualification testing.
• May require 10% of travel.
• English/Spanish bilingual as a must.