Project Engineer- 1st shift

Our Client specializes in medical device manufacturing. We are looking to fill a Project Engineer for them; this is a direct hire opportunity.

Here is a snapshot of the role:

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

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