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Nitinol Materials Manufacturing Engineer, Senior Staff (Fremont)

Nitinol Materials Manufacturing Engineer, Senior Staff (Fremont)

Confluent MedicalFremont, CA, United States
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Manufacturing Engineer, Senior Staff

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include : Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We are looking for a Manufacturing Engineer, Senior Staff to join our talented Nitinol Materials team in Fremont, CA, specializing in Nitinol tubing and wire. As a uniquely qualified candidate, you will have :

  • Ability to perform root cause analyses on the production floor when nonconformances arise and implement strategically chosen corrective actions.
  • Oversee and manage all aspects of preventive and corrective maintenance, including budget management and expenditure tracking.
  • Lead Cost Improvement Projects (CIP) by identifying opportunities for cost reduction and process enhancements.
  • Manage and trace Cost of Poor Quality (COPQ) metrics, initiating and leading projects to reduce COPQ.
  • Support product transfers and manage calibration activities, including budgeting for calibration expenses.
  • Develop and foster a relationship with the product development team to streamline products into high volume production.
  • Troubleshoot equipment issues on the production floor in conjunction with maintenance and technicians.
  • Partner with supply chain to plan equipment downtime for critical maintenance events.
  • Drive sustainable solutions to complaints from both internal and external customers by means of change management.
  • Be able to lift up to 40 pounds occasionally and spend up to 80% of the day on the production floor in environments that could require the use of PPE (personal protective equipment).
  • Work in collaboration with operators, technicians, and process engineers to deliver materials products that meet customer requirements.
  • May technically supervise or coordinate the work engineers, draftspersons, technicians, and others who assist in specific assignments. Ability to guide junior engineers through the learning process. Document knowledge and create resources to ensure proper training for engineers.
  • Able to thrive in an environment where decisions can be derived from sometimes ambiguous situations.
  • Develop a working understanding of the cost of production by analyzing BOM / MOM structure and subsequently improve the cost of manufacture.
  • Ability to perform yield analysis, as well as the respective scrap rate analysis. Must be able to identify the main causes and address them with solid action plans.

Education / Qualifications :

  • Minimum of 9 years of industrial / manufacturing experience, specifically in metalworking
  • Bachelor's degree in Engineering (Mechanical, Industrial, or similar)
  • Understanding of Nitinol materials
  • Advanced analytical skills using software such as SolidWorks, Minitab, etc.
  • LEAN manufacturing certification(s), Green Belt at a minimum
  • Extensive experience performing root cause analyses by means of fishbone, 5 why, etc.
  • Expert GD&T skills
  • Excellent communication skills, both written and oral
  • ERP System familiarity, such as Epicor
  • Preferred qualifications :

  • Expertise with tubing manufacturing, specifically drawing
  • Medical device manufacturing experience with ISO 13485
  • Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include : Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

    We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.

    Confluent Medical Technologies is an equal opportunity employer. Only qualified candidates will be contacted.

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    Senior Manufacturing Engineer • Fremont, CA, United States

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