Manufacturing Engineer II

Confluent Medical; Fremont (CA); On-site; USD 87,000 - 146,000; Full time

Job summary

Confluent Medical Technologies is seeking a Manufacturing Engineer II to support and optimize manufacturing processes in Nitinol materials. You will provide hands-on engineering support, drive continuous improvement, and partner cross-functionally to ensure high-quality, efficient production.

The role emphasizes process validation, data-driven problem solving, and collaboration with Operations, Quality, R&D, and Supply Chain to scale new materials and ensure production readiness.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related field.
• 2-5 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.
• Knowledge of tube conversion, strip processing, annealing, wire EDM, centerless grinding.
• 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.

Responsibilities

• Provide daily engineering support for material processing operations.
• Troubleshoot process, material, and equipment issues to minimize downtime and scrap.
• Develop, update, and maintain manufacturing documentation including work instructions, MOM/BOM configuration 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, yield, and throughput.
• Identify and implement cost reduction opportunities through process optimization and material utilization.
• Assist with transfer and scale-up of new Nitinol materials and processes into production.
• Execute process validation activities (IQ/OQ/PQ) and ensure compliance with internal requirements.
• Ensure adherence to FDA, ISO 13485, and internal quality system requirements.
• Partner with Quality to define process controls and inspection requirements.
• Collaborate across Operations, Quality, R&D, and Supply Chain; provide guidance to operators and junior engineers.

Education

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

Tools

Minitab

Job description

Manufacturing Engineer II### Manufacturing Engineer IIApply: Fremont: Full time: Posted Today: R-111729**Salary Range:**$87,400.00 - $145,600.00**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, II** is a junior level 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 on moderately complex problems and contributes to process scalability, cost efficiency, and product quality. # **Responsibilities****Manufacturing Engineering Support:*** Provide daily engineering support for material processing operations* Troubleshoot process, material, and equipment issues to minimize downtime and scrap* Develop, update, and maintain manufacturing documentation including work instructions, MOM/BOM configuration 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* 2-5 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* Knowledge of manufacturing processes such as tube conversion, strip processing, annealing, wire EDM, centerless grinding preferred.* 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* Continuous improvement mindset **Additional Information**Work Environment: Manufacturing floor and office environment supporting Nitinol materials production### About Us****Applying materials science to MedTech innovation.****Confluent specializes in expert design and development of large-scale manufacturing specializing in interventional catheter-based devices and implants. Our key capabilities include Nitinol components and tubing, balloon and complex catheters, high-precision polymer tubing, and implantable textiles. We operate in 8 state-of-the-art facilities across the United States and Costa Rica and currently employ over 2,000 employees. Confluent has earned the confidence of leaders in the medical device community through a proven track record of innovation, engineering, and manufacturing.Visit www.confluentmedical.com to learn more.