Staff Manufacturing Engineer

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 is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life‑saving solutions to our customers through a collaborative and high‑impact work environment. Our moderate size, diversity of technologies, and broad material science capabilities provide an environment in which our employees can develop broad skill sets and directly influence product development and manufacturing outcomes.

The Manufacturing Engineer, Staff is a fully competent individual contributor responsible for supporting and optimizing manufacturing processes within the Nitinol Materials operations. This role provides hands‑on engineering support, drives continuous improvement initiatives, and partners cross‑functionally to ensure high‑quality, efficient production of Nitinol materials. The role operates with minimal supervision on moderately complex problems and contributes to process scalability, cost efficiency, and product quality.

Responsibilities

Manufacturing Engineering Support

• 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

Process Improvement

• 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

New Product & Process Introduction

• 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

Quality & Compliance

• Ensure adherence to FDA, ISO 13485, and internal quality system requirements
• Support nonconformance investigations, root cause analysis, and corrective/preventive actions (CAPA)
• Partner with Quality to define process controls and inspection requirements
• Collaboration & Technical Contribution:
• 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

Qualifications

Education & Experience

• 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
• Technical Skills:
• Knowledge of manufacturing processes such as melting, heat treatment, forming, machining, or finishing
• Experience with statistical analysis and data‑driven problem solving (e.g., Minitab)
• Familiarity with process validation (IQ/OQ/PQ)
• Ability to interpret engineering drawings and GD&T

Core Competencies

• Strong analytical and problem‑solving skills
• Ability to work independently with sound technical judgment
• Effective communication and cross‑functional collaboration
• High attention to detail with a focus on quality and compliance

Additional Information

Work Environment: Manufacturing floor and office environment supporting Nitinol materials production

Travel: Up to 10% as needed

FLSA Status: Exempt

Equal Opportunity Employer

Confluent Medical Technologies is an equal opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.