What are the responsibilities and job description for the Manufacturing Engineer position at Skills Alliance?
A transformative Medical Device organization with an innovative portfolio is expanding their team in Georgia. They are seeking a driven and innovative engineer to lead the development and scaling of advanced manufacturing processes for complex, high-precision devices. This is a hands-on position within a dynamic R&D environment focused on transitioning prototypes into scalable production lines. Ideal for individuals passionate about engineering excellence, continuous improvement, and production innovation.
Responsibilities
- Drive the transformation of product concepts into efficient, scalable manufacturing workflows.
- Develop and optimize manufacturing methods for pilot-scale through full-scale production.
- Work cross-functionally to ensure that engineering designs align with best practices for manufacturability.
- Create and implement process improvements to enhance efficiency, throughput, and product consistency.
- Design and build custom fixtures, jigs, and tooling necessary for production and testing.
- Serve as a bridge between development and manufacturing teams for process handoff and operator training.
- Manage supplier engagement for outsourced components, assemblies, and equipment.
- Lead equipment qualification, process validation, and production verification efforts.
- Continuously seek opportunities for cost reduction, quality improvement, and workflow optimization.
- Draft and maintain clear, precise documentation and standard operating procedures.
- Track progress of multiple concurrent projects, ensuring timelines and budgets are met.
- Adhere to applicable regulatory standards for quality and compliance in production environments.
- Identify potential risks to delivery schedules and recommend mitigation strategies proactively.
Requirements:
- Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline
- 7 years in engineered product manufacturing within regulated sectors (e.g., life sciences, high-tech medical, or similar)
- Minimum 3 years directly designing and optimizing production processes for disposable or small-scale precision devices
- High proficiency in 3D CAD (SolidWorks or equivalent) for equipment/tooling design
- Strong experience in Design for Manufacturability (DFM), automation integration, and production cell layout
- Familiarity with regulatory frameworks governing manufacturing (GMP, FDA, ISO)
- Comfort with technical drawings, mechanical tolerances, and circuit schematics
- Solid understanding of diverse production techniques including molding, stamping, extrusion, coatings, and additive manufacturing
- Effective communicator with excellent time and project management skills
Please contact emily.james@skillsalliance.com for information.