Manufacturing Engineer II

Location: US CA San Jose

Circulation

ZOLL Medical is a growing, innovation-driven company at the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success. The Circulation team is focused on “beating heart” therapies for hospitals. Post-cardiac arrest, STEMI heart attack, and severe fever are some of the applications of ZOLL’s unique devices. Fully integrated, ZOLL Circulation research, develops, manufactures, and sells novel technologies includes ZOLL Temperature Management Solutions and TherOx SSO2 Therapy. Temperature Management Solutions empower physicians to “prescribe” a temperature and achieve it. TherOx SSO2 Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks. We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

The position is responsible for developing, implementing, and validating processes and procedures to manufacture electromechanical and catheter-based medical devices in full compliance with the company’s quality system.  Apply Lean concepts to reduce waste and maximize efficiency.  Troubleshoot production issues.  Work with vendors to drive cost reductions to existing components and assemblies.

Essential Functions:

  • Works closely with R&D engineers during the product design phase to ensure Design for Manufacturability requirements are considered and implemented.  Understands the product design to implement and improve manufacturing processes.
  • Develops and improves existing manufacturing methods, fixtures and assembly aids.
  • Analyzes and documents workflow.  Works with production to layout equipment and workspace for maximum efficiency.
  • Works with vendors to address issues and to identify opportunities to reduce cost.  Coordinates efforts with Supplier Quality Engineer.
  • Troubleshoots production issues and implements appropriate solutions.  Uses DOE techniques to characterize and improve processes and production yields.
  • Creates verification and validation test protocols and reports including equipment IQ/OQ/PQ as required.
  • Dispositions Non-Conformance Reports and Corrective and Preventive Actions as assigned.
  • Trains Operators on new or modified processes.
  • Ensures all production equipment is properly calibrated and maintained.
  • Facilitates communication between all team members.
  • Provides leadership, direction, and ownership in areas of manufacturing engineering and process development.
  • Performs and documents Process Failure Modes and Effects Analysis as needed.
  • Performs other tasks as assigned by their supervisor.

Skill Requirements:

  • Attention to detail
  • Excellent problem-solving skills
  • Solid background in electrical, mechanical, and/or materials engineering
  • Excellent written and verbal communication skills
  • Self-directed
  • Effectively prioritizes and manages the completion of multiple projects
  • Able to collaborate effectively in cross-functional teams
  • Able to use Solid Works or Pro-E to document fixtures and assembly aids

Education/Training/Experience Requirements:

  • B.S. in Mechanical Engineering
  • 3-7 years manufacturing engineering experience, preferably in a regulated environment 
  • Experience with Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process Failure Mode and Effects Analysis (FMEA)
  • Solid Works experience a plus.
  • Catheter manufacturing experience a plus.

Preferred Experience:

  • Medical device manufacturing involving electromechanical and/or catheter-based products
  • Lean methodologies
  • FDA, ISO

The annual salary range for this position can range from $80,000 - $125,000. The actual compensation may vary outside of this range depending on geographic location, work experience, education, and skill level. 

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.