Sr. Engineer, Manufacturing

About Company:

About us:

Gener8 is an innovative tech company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica. We know what it takes to be a key partner in the life science and medical device industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering and software design services and manufacturing complex instruments and consumables. Our customers are striving for breakthroughs in medical research and diagnostic applications as well as surgical devices that help scientists and medical professionals understand and diagnose diseases and improve patient treatment outcomes.

About the Role:

The Senior Engineer, Manufacturing, plays a critical role in driving the efficiency, quality, and innovation of manufacturing processes within our Carlsbad, CA facility. This position is responsible for leading the design, development, and implementation of advanced manufacturing solutions that support product scalability and cost-effectiveness. The role requires close collaboration with cross-functional teams including design engineering, quality assurance, and production to ensure seamless integration of new technologies and continuous process improvements. The Senior Engineer will also analyze manufacturing data to identify bottlenecks and develop strategies to enhance throughput and reduce waste. Ultimately, this position ensures that manufacturing operations meet rigorous standards for safety, quality, and productivity while supporting the company’s strategic growth objectives.

Minimum Qualifications:

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field.
• 5+ years of experience in a manufacturing engineering role within a high-tech or industrial environment.
• Strong knowledge of manufacturing processes, tooling, and equipment.
• Proficiency with CAD software and manufacturing simulation tools.
• Experience with process improvement methodologies such as Lean or Six Sigma.

Preferred Qualifications:

• Bachelor's or Master’s degree in Engineering or related discipline.
• Certification in Six Sigma (Green Belt or Black Belt) or Lean Manufacturing.
• Experience with automation and robotics integration in manufacturing.
• Familiarity with quality management systems such as ISO 9001 or AS9100.
• Previous experience working in a regulated industry such as medical devices or aerospace.

Responsibilities:

• Lead the development and optimization of manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• Collaborate with product design and quality teams to ensure manufacturability and compliance with industry standards.
• Analyze production data and metrics to identify areas for process improvement and implement corrective actions.
• Develop and document manufacturing procedures, work instructions, and process controls.
• Support the introduction of new products by designing scalable manufacturing solutions and conducting pilot runs.
• Troubleshoot manufacturing issues and provide technical guidance to production teams.
• Drive continuous improvement initiatives using Lean, Six Sigma, or other methodologies.
• Ensure compliance with safety regulations and maintain a safe working environment.

Skills:

The required skills enable the Senior Engineer to design and refine manufacturing processes that enhance product quality and operational efficiency. Proficiency in CAD and simulation tools is essential for developing and validating manufacturing workflows and tooling designs. Knowledge of Lean and Six Sigma methodologies supports the identification and elimination of waste, driving continuous improvement initiatives. Preferred skills such as automation integration and quality system familiarity allow the engineer to implement advanced manufacturing technologies and ensure compliance with industry standards. Strong analytical and problem-solving skills are applied daily to troubleshoot production challenges and optimize process performance.