Manufacturing Engineer II

Confluent Medical Technologies•Fremont, CA
•$87,400 - $145,600

About The Position

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 works cross-functionally to promote high-quality, efficient production of Nitinol materials. It addresses moderately complex problems and contributes to process scalability, cost efficiency, and product quality. The position supports material processing operations, troubleshoots process, material, and equipment issues, maintains manufacturing documentation, monitors process performance, and implements improvements. It also supports new-product and process development, production transfer and scale-up, process validation, and compliance with quality-system requirements. The work takes place in manufacturing-floor and office environments supporting Nitinol materials production.

Requirements

  • Bachelor’s degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or a related field.
  • 2–5 years of manufacturing engineering experience.
  • 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.
  • 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.

Nice To Haves

  • Experience in a regulated manufacturing environment, such as medical device or aerospace.
  • Experience with metals processing; Nitinol or specialty alloys strongly preferred.
  • Knowledge of manufacturing processes such as tube conversion, strip processing, annealing, wire EDM, or centerless grinding.

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 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.
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