Rapid Development Engineer

Confluent Medical Technologies; Fremont (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading company in medical device innovation is seeking a Rapid Development Engineer to optimize production processes and support pilot production lines. This role involves collaboration with engineering teams and a focus on process validation and optimization in a fast-paced environment.

Qualifications

• At least 9 years of experience in medical device manufacturing.
• Expertise in GD&T principles and medical device processing standards.

Responsibilities

• Optimize production processes for efficiency, quality, and yield.
• Drive process validation, statistical analysis, and DOE methodologies.

Skills

Effective communication

Collaboration

Education

Bachelor's in Mechanical Engineering

Tools

SolidWorks

Job description

Join to apply for the Rapid Development Engineer role at Confluent Medical Technologies

Job Description

Confluent Medical Technologies is a leader in medical device innovation, specializing in material science, engineering, and manufacturing. We develop high-quality, scalable solutions including nitinol components, balloon catheters, and guidewires. We are seeking a Process Development Engineer, Senior Staff to support our new medical device pilot production line in our ISO 13485-registered facility. This role offers the opportunity to influence manufacturing processes and develop cutting-edge medical technologies.

Key Responsibilities

1. Optimize production processes for efficiency, quality, and yield.
2. Manage manufacturing and shipment of pilot builds for internal and external clients.
3. Implement Lean manufacturing, optimize line layouts, and streamline workflows.
4. Train and collaborate with engineering and technical staff to improve manufacturing techniques.
5. Analyze process changes throughout product lifecycle as a subject matter expert.
6. Drive process validation, statistical analysis, and DOE methodologies, with about 10% travel.
7. Contribute to PFMEA, MVP, and process validation protocols.
8. Manage CAPA investigations and root cause analyses to improve reliability.
9. Troubleshoot equipment, process, and design issues to meet project goals.
10. Coordinate with customers and cross-functional teams to align engineering solutions.
11. Perform additional tasks as delegated by management.

Qualifications

• Expertise in GD&T principles and medical device processing standards.
• Effective communication skills in a technical environment.
• Ability to work in a fast-paced, deadline-driven setting while fostering collaboration.

Education & Experience

• Bachelor's or higher in Mechanical Engineering or related field.
• At least 9 years of experience in medical device manufacturing within an ISO 13485 environment.
• SolidWorks skills for process and fixture development.
• Knowledge of polymer and metal materials like Nylon, Parylene, Pebax, PEEK, Stainless steels, Nitinol.
• Proficiency in statistical analysis and process optimization techniques.
• Experience with machining, extrusion, bonding, welding, 3D printing, and thermo-mechanical processes.

We are committed to equal opportunity employment. We cannot sponsor visas or consider individuals on time-limited visas for this role. Only qualified candidates will be contacted.