Job Description

Job Description Manufacturing Engineering Manager Staunton, Virginia | Full-Time | On-Site Are you a seasoned engineering leader who thrives in fast-paced, highly regulated environments? Do you have a passion for elevating teams, transforming culture, and exceeding expectations in the medical device industry? This is your opportunity to make a strategic impact at a site focused on precision, quality, and customer satisfaction. Why Join Us? This is more than a leadership role—it's a mission-critical position where your expertise will help shape not only products, but also people and processes. We’re looking for someone who can drive operational excellence, support business growth, and build a team that delivers confidence to top-tier medical device customers . What You’ll Be Doing: Lead & Develop a High-Performing Team Manage and mentor engineers, technicians, and facilities professionals in a dynamic production environment. Provide clear direction and structure while inspiring accountability and engagement. Lead a cultural shift toward greater responsiveness, technical excellence, and customer-centric thinking. Drive Manufacturing Performance Optimize manufacturing processes for scalability, efficiency, and world-class quality. Lead Lean, Six Sigma, and continuous improvement efforts. Ensure smooth product transfer from R&D into scalable, validated production. Ensure Compliance & Quality Maintain compliance with FDA, ISO 13485, and GMP standards. Lead validation (IQ, OQ, PQ) and maintain audit-ready documentation. Anticipate customer expectations and proactively raise performance benchmarks. Implement Technology & Innovation Oversee equipment installation, maintenance, and modernization efforts. Introduce automation, robotics, and other smart manufacturing tools. Own Problem-Solving & Metrics Lead structured root cause analysis and resolution of production challenges. Drive data-backed decision-making and continuous improvement through KPI tracking. Collaborate & Influence Partner across Quality, Regulatory, R&D, Operations, and external suppliers to ensure manufacturing readiness. Serve as a technical ambassador to medical device customers , building trust and demonstrating capability. Build Talent & Capability Design and deliver training programs that ensure regulatory compliance and team development. Keep the team current with the latest in manufacturing technology and industry standards. What You Bring: Bachelor’s degree or higher in Manufacturing Engineering or a related field. Proven leadership experience in a medical device contract manufacturing environment —with a track record of culture change and customer satisfaction. Deep knowledge of FDA regulations, ISO 13485, GMP, and validation processes. Strong leadership, change management, and communication skills. Hands-on, floor-engaged management style. Proficiency in Microsoft Suite, CAD software, and data-driven tools. PMP certification or formal leadership training is a strong plus. Work Environment This is a fully onsite leadership position . You’ll split time between the office and production floor—coaching your team, collaborating with peers, and delivering results that make a difference to our customers and our business. If you're ready to lead transformation, drive excellence, and make your mark in medical device manufacturing , we’d love to hear from you. Tucked in the scenic Shenandoah Valley, Staunton blends historic charm , modern culture , and outdoor adventure —all with a lower cost of living and easy access to Charlottesville, Richmond, and D.C. It’s a great place for: Professionals in manufacturing or engineering Families seeking safe, walkable neighborhoods Anyone who enjoys mountains, fresh air, and weekends spent off the grid From live theater and craft breweries to hiking, fishing, and yes— plenty of room to roam —Staunton offers a lifestyle that’s both grounded and enriching. Looking for your next move? This town is ready to surprise you.

Job Tags

Full time, Contract work, Work at office, Shift work,

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