We are looking for a
Continuous Improvement/Integration Engineer who thrives in a small, fast-paced environment and wants to play a hands-on role in bringing innovative medical devices from concept to market. This position is based in our Suwanee, Georgia office and is responsible for supporting the integration of new products into manufacturing while driving ongoing improvements in product efficiencies and cost-effectiveness. This role focuses on enhancing manufacturing processes through simplification, waste reduction, automation, and cost-saving initiatives. Key responsibilities include reducing scrap, lowering material costs, increasing operational efficiency, and implementing sustainable process improvements to support high-quality and cost-efficient production.
Core Responsibilities:- Develop, implement, and validate manufacturing processes and equipment to support efficient and high-quality product production
- Update INFOR Bills of Materials (BOMs) and cost standards for both existing and new products
- Conduct time studies as needed to establish accurate manufacturing standards and identify opportunities for efficiency improvements
- Collaborate closely with Research & Development (R&D) team to ensure smooth transition of new projects into manufacturing operations
- Promote a culture centered on customer satisfaction, quality initiatives, and continuous improvement
- Develop and maintain key quality and cost metrics, and proactively pursue cost savings through lean manufacturing, process optimization, and capital investments
- Ensure compliance with applicable FDA and ISO regulations, particularly in the areas of traceability, equipment maintenance, and process validation
- Uphold facility cleanliness and housekeeping standards to support a safe and efficient work environment
- Partner with R&D, Marketing, and Quality teams on product enhancements or modifications to ensure designs are optimized for manufacturability
- Maintain a safe work environment in compliance with all relevant federal and state health and safety regulations
- Implement mistake-proofing strategies (poka-yoke) to minimize the risk of quality defects
- Collaborate with suppliers to enhance the quality and robustness of incoming materials and reduce nonconformances
- Establish and manage systems to track scrap, rework, and nonconformances, with the goal of reducing manufacturing costs over time
- Work is performed in a normal manufacturing environment with exposure to production equipment and materials
- Must be able to sit, stand, walk, bend, and move about for extended periods throughout the work day. Ability to lift and carry light to moderately heavy materials as needed.
- Must be able to access a cleanroom and use personal protective equipment (PPE) properly throughout the day. Most work will be completed within a controlled cleanroom environment.
What We're Looking For: Required:- Bachelor's degree in a technical field and/or 5+ years of manufacturing experience
- Lean and/or Six Sigma experience
- Experience utilizing a Quality System and ERP System
- Knowledge of GMP regulatory requirements
- Ability to solve problems and implement project plans
Preferred:- Bachelor of Science in Engineering field
- Experience using INFOR as an ERP system
- Holds Lean/Six Sigma Certification
- 3+ years' experience in a Class III medical device manufacturer
- Medical design engineering experience
