Manufacturing Engineer II

Confluent Medical•Fremont, CA

About The Position

Confluent Medical Technologies is a financially healthy, rapidly growing medical device company with a collaborative, high-impact work environment. The company’s moderate size, diverse technologies, and broad material science capabilities offer employees opportunities to develop broad skill sets and influence product development and manufacturing outcomes. The Manufacturing Engineer II is a junior-level individual contributor who supports and optimizes manufacturing processes within Nitinol Materials operations. The role provides hands-on engineering support, drives continuous improvement, and partners cross-functionally to help ensure high-quality, efficient production of Nitinol materials. Working on moderately complex problems, the engineer contributes to process scalability, cost efficiency, and product quality.

Requirements

Bachelor’s degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or a related field.
2–5 years of manufacturing engineering experience.
Strong analytical and problem-solving skills.
Ability to work independently with sound technical judgment.
Effective communication and cross-functional collaboration skills.
High attention to detail with a focus on quality and compliance.
A continuous improvement mindset.

Nice To Haves

Experience in a regulated manufacturing environment, such as medical device, aerospace, or similar.
Experience with metals processing; Nitinol or specialty alloys are strongly preferred.
Knowledge of manufacturing processes such as tube conversion, strip processing, annealing, wire EDM, and centerless grinding.
Experience with statistical analysis and data-driven problem solving, such as 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 (Cp/Cpk), yield, and throughput.
Identify and implement cost-reduction opportunities through process optimization and material utilization.
Support the 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 corrective/preventive actions (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.