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Project Engineer

Vantage Point Recruiting

Rochester, NH

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JOB DETAILS
SKILLS
3D Printing, Automation, Best Practices, Biomedical Engineering, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Communication Skills, Continuous Improvement, Cost Control, Cross-Functional, Documentation, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), Hand Tools, ISO (International Organization for Standardization), Leadership, Leading Edge Technology, Lean Manufacturing, Machine Tool, Machining, Manufacturing, Manufacturing Requirements, Manufacturing/Industrial Processes, Marketing, Mechanical Engineering, Medical Equipment, Mentoring, Organizational Skills, Procedure Development, Process Improvement, Process Validation, Product Design, Product Development, Project Engineering, Project Execution, Project/Program Management, Quality Assurance Methodology, Quality System Requirements (QSR), Research & Development (R&D), Risk Management, SolidWorks, Supplier Optimization, Supply Chain, Systems Engineering, Technical Recruiting, Vendor/Supplier Relations
LOCATION
Rochester, NH
POSTED
30+ days ago

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

 

 

About the Company

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Vantage Point Recruiting