Manager, Continuous Improvement

at  Sequel Medical Technology

ABOUT SEQUEL

Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.

JOB OVERVIEW

Sequel Med Tech is seeking a highly skilled Manager, Continuous Improvement to join our dynamic team. The ideal candidate will play a pivotal role in developing and optimizing efficient, scalable processes across the organization. This individual will collaborate with cross-functional teams to streamline operations, enhance product quality, and drive innovation in the medical device sector.

MINIMUM REQUIREMENTS

• Education: Bachelor’s degree in Engineering, preferably in Mechanical, Industrial, or Chemical Engineering. Advanced degree preferred.
• Experience: 5+ years of experience in process engineering, preferably within the medical device industry.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Strong understanding of manufacturing processes, including machining, assembly
• Proficiency in statistical analysis tools (e.g., Minitab, JMP) and process optimization methodologies (e.g., Six Sigma, Lean Manufacturing).
• Experience with regulatory requirements for medical devices, such as FDA 21 CFR Part 820 and ISO 13485.
• Excellent communication skills with the ability to collaborate effectively across multidisciplinary teams.
• Proven track record of driving process improvements, cost reductions, and quality enhancements.
• Ability to work independently, prioritize tasks, and manage multiple projects simultaneously.
• Detail-oriented mindset with a passion for innovation and continuous learning.
  Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

• Lead the design, development, and optimization of organizational processes for medical devices, focusing on efficiency, scalability, and compliance.
• Collaborate across all functions to identify process improvement opportunities and implement solutions.
• Utilize engineering principles and statistical methods to analyze process data, identify trends, and drive continuous improvement initiatives.
• Ensure compliance with regulatory standards, including FDA regulations and ISO requirements, throughout the product development lifecycle.
• Design and execute validation protocols for new processes, equipment, and facilities, ensuring adherence to quality standards and regulatory requirements.
• Provide technical expertise and support for troubleshooting manufacturing issues and implementing corrective actions.
• Develop and maintain documentation, including SOPs, work instructions, and process flow diagrams, to support operations.
• Stay current with industry trends, best practices, and technological advancements in the medical device field.