Job Description

About Zenflow

Zenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal function while preserving the natural anatomy. The Zenflow Spring System is an investigational device and is not approved for commercial sale.

Position Overview

We are a dynamic medical device start-up seeking a highly skilled and motivated Senior Manufacturing Engineer to join our team. The ideal candidate will play an important role in scaling up clinical stage disposable medical devices in preparation for commercialization, focusing on equipment and process development, cost reduction, yield improvement, assembly time reduction, and production support.

Major Duties and Responsibilities

• Design, implement, and improve manufacturing processes and systems, focusing on efficiency, cost-effectiveness, and quality, while ensuring compliance with safety and regulatory standards.
• Update clinical manufacturing process instructions to clarify language and align with current manufacturing methods.
• Define and document cleanroom lines and production flow.
• Employ rigorous problem-solving techniques to quickly identify root causes and propose solutions to minimize line downtime during production.
• Manage production schedule and assembly staff.
• Ensure assembly staff are properly trained and that training records are maintained according to Quality Management Procedures.
• Manage vendors and their schedules to obtain parts, assemblies, and equipment in a cost-effective and expedited manner.
• Develop and conduct process validation testing protocols and document results.
• Ensure that processes/methods utilized are consistent with cost-effective and reliable manufacturing practices.
• Identify and propose improvements to increase production throughput, minimize scrap, or improve quality of manufacturing processes.
• Work with R&D engineers and vendors to implement product and process changes that reduce labor content, increase process capability, and simplify component fabrication and assembly methods.
• Complete projects in a timely manner consistent with corporate objectives.
• Maintain current knowledge of competitive technologies and medical, technical, biomedical developments related to the company's products.
• Provide support in resolving product complaints and safety issues.
• Support company goals, policies, procedures, and adherence to QSR and FDA guidelines.
• Use SolidWorks to create designs for manufacturing fixtures and equipment and generate relevant engineering specifications.
• Work from verbal, written, or pictorial information to create designs and implement improvements for engineering staff.

Education/Experience Requirements

• Bachelors degree in Mechanical Engineering or equivalent preferred.
• Minimum of 5 years related experience in the medical device industry.
• Experience with injection molding, electronics component fabrication and assembly processes, welding, thermal and adhesive bonding, and additive/subtractive manufacturing methods.
• Experience with assembly methods for disposable medical devices.
• Experience scaling up products into Pilot or Production environments.
• Prefer advanced mechanical design experience and knowledge of catheter assembly techniques/technologies.
• Ability to work independently and manage multiple priorities in a fast-paced, FDA-regulated environment.
• Strong verbal and written communication skills.
• Strong organizational and planning skills with attention to detail.

This position is based in South San Francisco, CA. The expected salary range is $120,000 - $145,000 plus equity and comprehensive benefits. Final compensation will depend on skills, experience, and education.

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