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Project Engineer

Vantage Point Recruiting

Project Engineer

Our client specializes in medical device manufacturing. They are looking to hire a Project Engineer, as a direct hire.

What you will be doing:

  • Spearhead end-to-end product development for groundbreaking medical device programs, guiding projects from initial concept through successful production launch
  • Design products and tooling hands-on using SolidWorks CAD, 3D printing technologies, manual machining, and precision hand tools
  • Bridge communication between internal teams and customers as the primary liaison, ensuring perfect alignment on strategy, deliverables, and critical timelines
  • Orchestrate cross-functional excellence by coordinating seamless activities between R&D, Quality, Regulatory, Manufacturing, Marketing, and Supply Chain
  • Launch new production lines with expert oversight of procedure development, line clearance protocols, and comprehensive operator training
  • Champion quality and compliance by providing hands-on support for manufacturing processes and quality systems (FDA QSR, ISO 13485)
  • Drive validation success through IQ/OQ/PQ/PPQ activities, Test Method Validations, and rigorous Process Characterization
  • Lead continuous improvement initiatives to enhance project execution, documentation quality, and system efficiencies
  • Deliver compelling communications on project status, milestones, risks, and mitigation strategies to all stakeholders including executive leadership
  • Mentor rising talent by developing junior engineers and strengthening team capabilities in project management and engineering best practices
  • Optimize supplier relationships to resolve challenges, identify opportunities, and elevate performance standards
  • Uncover cost-saving opportunities through innovative process improvements, automation solutions, and lean manufacturing principles

What you bring:

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related engineering discipline
  • 7+ years of proven experience in regulated medical device manufacturing or product development
  • Advanced proficiency in SolidWorks and cutting-edge design technology solutions
  • Exceptional documentation, organizational, and communication abilities
  • In-depth knowledge of FDA regulations, ISO 13485, and GMP requirements
Vacancy posted 2 days ago
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