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Continuous Improvement/Integration Engineer

Suwanee, United States

About Femasys Inc.
Femasys Inc. is a leading biomedical company dedicated to advancing women’s healthcare through innovative medical solutions. Our mission is to provide safe, effective, and accessible products that improve women's lives worldwide.

Position Summary:

The Continuous Improvement/Integration Engineer is responsible for supporting the integration of new products into manufacturing while driving ongoing improvements in production efficiency 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-

Specific Job Functions:

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 the 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.

Physical Requirements:

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 workday.
Regularly required to work with and around various types of manufacturing equipment.
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.
Ability to lift and carry light to moderately heavy materials as needed.

Minimum Qualifications, Education & Work Experience:

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 Qualifications, Education & Work Experience