Job Description

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 LSO 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