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.

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