Staff Manufacturing Engineer - Nitinol Process & Quality

Confluent Medical Technologies; Fremont (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Confluent Medical Technologies in Fremont, CA is seeking a Staff Manufacturing Engineer to support and optimize Nitinol materials production. The role provides hands-on engineering, leads continuous improvement, and partners across functions to ensure scalable, high-quality manufacturing.

Candidates should have a mechanical engineering background with 5+ years in a regulated setting, familiarity with IQ/OQ/PQ, and experience in metals processing.

Qualifications

• Bachelor's degree in Mechanical Engineering, Materials Science, or a related field.
• 5+ years of manufacturing engineering experience in regulated environments.
• Experience with metals processing and Nitinol or specialty alloys preferred.
• Familiarity with IQ/OQ/PQ validation and documentation.

Responsibilities

• Provide hands-on engineering support for Nitinol melting, casting, and downstream processing.
• Lead continuous improvement using Lean and Six Sigma methods.
• Ensure compliance with FDA/ISO 13485 and internal quality systems.
• Collaborate with Operations, Quality, R&D, and Supply Chain to drive product quality and cost efficiency.

Skills

Statistical analysis

Minitab

Problem-solving

Education

Bachelor's degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related field

Tools

GD&T

IQ/OQ/PQ documentation

Job description

Confluent Medical Technologies in Fremont, CA is seeking a Staff Manufacturing Engineer to support and optimize Nitinol materials production. The role provides hands-on engineering, leads continuous improvement, and partners across functions to ensure scalable, high-quality manufacturing.

Candidates should have a mechanical engineering background with 5+ years in a regulated setting, familiarity with IQ/OQ/PQ, and experience in metals processing.