Staff Manufacturing Engineer - Nitinol & Process Improvement

CONFLUENT MEDICAL TECHNOLOGIES INC.; Colorado; On-site; USD 90,000 - 125,000; Full time

Job summary

Confluent Medical Technologies in Colorado seeks a Manufacturing Engineer with 5+ years in a regulated environment to support Nitinol melting, casting, and downstream processing. You will troubleshoot, develop docs, and drive continuous improvement across quality, operations, and R&D teams.

Responsibilities include process validation (IQ/OQ/PQ), Cp/Cpk improvements, and cost reductions while ensuring FDA/ISO 13485 compliance. Travel up to 10% may be required.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related field.
• 5+ years of manufacturing engineering experience.
• Experience in a regulated manufacturing environment (medical device, aerospace, or similar) preferred.
• Experience with metals processing; Nitinol or specialty alloys strongly preferred.

Responsibilities

• Provide daily engineering support for Nitinol melting, casting, and downstream material processing operations.
• Troubleshoot process, material, and equipment issues to minimize downtime and scrap.
• Develop, update, and maintain manufacturing documentation including work instructions and process specifications.
• Monitor and analyze process performance and implement improvements.
• Lead and support continuous improvement initiatives using Lean and Six Sigma methodologies.
• Improve process capability (Cp/Cpk), yield, and throughput.
• Identify and implement cost reduction opportunities through process optimization and material utilization.
• Support transfer and scale-up of new Nitinol materials and processes into production.
• Assist with process development, manufacturability assessments, and production readiness.
• Execute process validation activities (IQ/OQ/PQ) and ensure compliance with internal requirements.
• Ensure adherence to FDA, ISO 13485, and internal quality system requirements.
• Support nonconformance investigations, root‑cause analysis, and CAPA.
• Partner with Quality to define process controls and inspection requirements.
• Partner cross‑functionally with Operations, Quality, R&D, and Supply Chain.
• Provide technical guidance to operators, technicians, and junior engineers.
• Contribute to a culture of safety, accountability, and continuous improvement.

Skills

Manufacturing processes

Statistical analysis

Process validation IQ/OQ/PQ

GD&T interpretation

Cross-functional collaboration

Attention to detail

Education

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

Tools

Minitab

Job description

Confluent Medical Technologies in Colorado seeks a Manufacturing Engineer with 5+ years in a regulated environment to support Nitinol melting, casting, and downstream processing. You will troubleshoot, develop docs, and drive continuous improvement across quality, operations, and R&D teams.

Responsibilities include process validation (IQ/OQ/PQ), Cp/Cpk improvements, and cost reductions while ensuring FDA/ISO 13485 compliance. Travel up to 10% may be required.