Design & Development Engineer

Date
August 12, 2025
Department
Engineering
Manages
0
Direct report(s)
Reports To
Development Engineering Manager
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Job Details

Summary:

The Design & Development Engineer is responsible for the development and validation of robust products, processes, assembly tools & methods, manufacturing processes, etc. for introduction into Robling Medical’s manufacturing environment. This position: 1) requires technical expertise in planning/conceptualizing, designing, implementing, modifying, optimizing, and validating products and manufacturing processes (including fabrication processes, assembly & test methods, packaging processes, tooling, fixtures & jigs, and manufacturing line layout); 2) conducts extensive DMFA analysis and proposes solutions to customers; 3) develops cost-effective components and efficient processes; and 4) is part of a team that ensures robust products and processes are ready for transfer to the Robling Medical manufacturing environment on time.

Primary Duties and Responsibilities

  • CAD/Drafting (Solidworks 3D modeling and Engineering Drawing development)
  • Product DFMA (Including Sterile Pkg & Shipping Configuration Design)
  • [Assembly] Process Development
  • Tooling/Fixture Design & Fabrication
  • Pilot MFG Line Design & Setup
  • Material Specifications, Bills of Material, Assembly & Packaging Instructions Development
  • Test Method Development & Validation
  • XFER to MFG Support - Finalizing Validation Docs, Line Setup & Training
  • Material, Vendor, Scale-up, Validation Strategy Support
  • Validation Protocol Development, Execution, and Reporting Support
  • Engineering & GRR Studies Development, Execution, & Reporting
  • Assistance with pFMEA Development and Maintenance
  • Assistance with Training Manufacturing Employees for all Developed Processes
  • Assistance in Ensuring Compliance/Adherence to Internal, Contract, FDA, & ISO Requirements

Required Qualifications

  • 4-year degree in an Engineering field (mechanical, industrial or electrical)
  • Technical skills in manufacturing processes and methods including flow, layout, assembly and production equipment
  • Strong in problem analysis and resolution: defines problem, collects data, establishes facts, draws valid conclusions and applies engineering principles to address any issues or concerns
  • Exceptional interpersonal and communication (both verbal and written) skills
  • Computer proficiency, including: CAD, Microsoft Office Products (Word, Excel, PowerPoint, Project)
  • Strong organizational and planning skills
  • Ability to manage multiple tasks, adhering to deadlines and commitments
  • Experience in troubleshooting and repairing equipment
  • Project management

Preferred Qualifications:

  • 3 years of experience minimum in a manufacturing environment.
  • Lean Six Sigma Green Belt Certification
  • Experience with heat sealing, vacuum forming, RF welding, high speed packaging lines, adhesive dispensing systems, cutting/punching/skiving/forming thermoplastics, inspection and test equipment (leak testing, scales, force gauges, etc.)
  • Experience with statistical software
  • Experience with electro-mechanical devices & equipment (design, fabrication/assembly, installation, qualification, operation)

Environment & Working Conditions:

This position is generally performed indoors in a plant or office environment and requires specific physical requirements that must be met, including:

  • Some heavy lifting and considerable moving of equipment (lifting up to 50 pounds)
  • Standing for long periods of time
  • Sitting for long periods of time
  • Bending
  • Ability to reach with hands and arms
  • Visual – Constant visual attention.