Rapid Development Engineer, Senior Staff

Salary Range:

$122,625.00 - $204,375.00

Job Description:

Confluent Medical Technologies is at the forefront of medical device innovation, transforming concepts into high-quality, scalable solutions. With unparalleled expertise in material science, engineering, and manufacturing, we collaborate closely with clients to bring their visions to life. Our core capabilities span nitinol components, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. As a recognized leader in the medical technology space, we are driven by a passion for developing products that improve lives worldwide.

We are expanding our team and seeking a Process Development Engineer, Senior Staff to support and refine our new medical device pilot production line in our ISO 13485-registered facility. This is a unique opportunity to shape cutting-edge manufacturing processes and play a pivotal role in the development of transformative medical technologies.

Key Responsibilities:

As a technical leader in process development, you will:

• Optimize production processes through expertise in materials, equipment, and medical device manufacturing best practices to enhance efficiency, consistency, and production yields.

• Facilitate the manufacturing and shipment of development and pilot manufacturing builds for both internal and external customers.

• Implement Lean manufacturing principles, optimize line layouts, and balance workflow for streamlined operations.

• Train and collaborate with engineers, skilled technicians, and assemblers to refine and scale robust manufacturing techniques.

• Act as the subject matter expert on process development—analyzing causal effects of changes throughout the product lifecycle.

• Drive process optimization for manufacturability, applying statistical techniques and DOE methodologies for validation and production transfer. This role involves approximately 10% domestic and international travel.

• Contribute to PFMEA, MVP, and process validation protocols, ensuring best-in-class quality standards.

• Navigate CAPA investigations, conduct root cause analyses, and implement corrective actions to enhance reliability.

• Be hands-on to troubleshoot issues related to equipment, process and design to meet project goals.

• Interface with customers and cross-functional teams, ensuring alignment between engineering solutions and project goals.

• Perform additional tasks and responsibilities as delegated by supervisor or senior management, ensuring alignment with organizational goals

Essential Qualifications:

• Expertise in GD&T principles and engineering standards for medical device processing, with a strong ability to interpret complex drawings and specifications.

• Clear, effective communication in a highly technical environment, demonstrating solution-oriented thinking and leadership.

• Ability to thrive in a fast-paced, deadline-driven setting while fostering collaboration and innovation.

Education & Experience:

• Bachelor's or advanced degree in Mechanical Engineering or related field.

• Minimum 9-years of experience in medical device manufacturing, preferably in an ISO 13485-compliant setting.

• SolidWorks modeling skills for process and fixture development.

• Practical knowledge of polymer and metal material science (e.g., Nylon, Parylene, Pebax, Polyurethane, PEEK, Stainless steels, Nitinol).

• Proficiency in statistical analysis techniques for process optimization.

• Experience in machining, extrusion, adhesive bonding, welding, 3D printing (polymers & metals), and thermo-mechanical processes.

Join Us!

At Confluent Medical Technologies, you’ll be part of a collaborative, forward-thinking team dedicated to advancing the future of medical devices. If you're passionate about process engineering and want to make a meaningful impact, we want to hear from you!