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 5 days ago
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