Development Project Manager

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

Summary:

The Development Project Manager is responsible for leading cross-functional project teams in the transfer of new products into manufacturing at Robling Medical. This position: 1) serves as project leader and primary point of contact for assigned development projects and Customers; 2) requires technical expertise in creating & maintaining project plans, tracking project performance and budget, developing & maintaining project & engineering reports, & communicating routinely on all aspects of projects to all stakeholders; 3) assists the Engineering team with the development of cost-effective, robust, & efficient processes, assembly tools & methods; and 4) leads cross functional teams in the transfer of products to the Robling Medical manufacturing environment on time.

Primary Duties and Responsibilities

Technical and Hands-on Leadership for the Following:

  • Customer Relationship & Project Team Leadership & Oversight (Customer Focus Team Leader)
  • Project File Setup & Maintenance
  • Project Scope & Cost Oversight/Control & Reporting
  • Cross Functional Team Leadership – Internal & External Resource Coordination for Engineering Projects (Including Scheduling & Tracking of ENG Builds)
  • MVP Initiation & Management thru V&V Phase
  • New Vendor Selection, Relationship Development, & Supply Chain Development Support
  • Material Specifications, Bills of Material, Assembly & Packaging Instructions Initiation
  • Product DFMA Assistance & Support (Including Sterile Pkg & Shipping Configuration Design)
  • Risk Analysis Support
  • [Assembly] Process Development Support
  • Test Method Development Support
  • CAD/Drafting & Tooling/Fixturing Support
  • MFG Line Design & Setup Support
  • Validation Protocol Development & Report Writing Support
  • XFER to MFG Support - Finalizing Validation Docs, Line Setup & Training
  • Department Procedure Development & Maintenance Support
  • Assistance in Ensuring Compliance/Adherence to Internal, Contract, FDA, & ISO Requirements
  • Assistance in Quoting New Business Opportunities

Required Qualifications

  • 4-year degree in a Scientific or Engineering field (Biomedical, Mechanical, Industrial or Electrical) with at least 2 years of experience in the field
  • Strong project management skills
  • Demonstrated ability to lead & manage a team
  • Excellent interpersonal skills & written communication
  • Strong analytical skills & attention to detail
  • Highly motivated self-starter with ability to drive for results
  • Demonstrated ability to effectively organize, prioritize & accomplish multiple tasks; makes decisions & solves problems independently
  • Background in medical device development & manufacturing
  • Experience working with medical device compliance to FDA & international standards
  • Experience in a fast-paced environment where ‘speed to market” is identified as a key performance indicator
  • Strong computer skills (MS Word, Excel, PowerPoint, Outlook, Project Management Tools, CAD, Statistical Software, Graphic Design Tools)

Preferred Qualifications:

  • Experience in an ISO 9001 or ISO 13485 manufacturing environment
  • Medical Device or Pharmaceutical development or manufacturing experience
  • Experience with device sterile packaging & terminal sterilization processes such as EtO, Gamma, etc.
  • Technical skills in manufacturing processes and methods including flow, layout, assembly and production equipment
  • Cross-discipline engineering experience
  • Experience in developing & maintaining pFMEAs
  • Experience in troubleshooting and repairing equipment
  • 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.)
  • Lean Six Sigma Green Belt Certification
  • Experience with MiniTab, SolidWorks, and 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