Project Engineer in Rochester

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Job DescriptionJob 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 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

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.