Job Details

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: The Principal R&D Engineer will serve as a technical leader, driving the design, development, and validation of advanced medical devices. This role requires a deep understanding of engineering principles, product development processes, and medical device regulations.

MAJOR DUTIES AND RESPONSIBILITIES:

1. Technical Leadership
   • Provide technical direction and oversight throughout the product development lifecycle.
2. Innovation and Problem Solving
   • Concept ideation and brainstorming based on known customer requirements and manufacturing scalability challenges.
   • Develop innovative solutions to challenging engineering problems.
3. Mechanical Design, Testing, and Analysis
   • Use Solidworks to create detailed designs and drawings.
   • Apply engineering analysis methods, including FEA, to proposed mechanical designs.
   • Conduct Verification/Validation activities, including product specification and test method development.
   • Maintain an accurate lab notebook and record of assignments and results.
4. Collaboration and Communication
   • Collaborate cross-functionally with clinical, regulatory, and manufacturing teams to ensure alignment and integration of technical requirements.
5. Mentorship
   • Mentor and develop junior engineers, fostering a culture of continuous learning and innovation.
6. Quality and Regulatory Compliance
   • Ensure that designs meet all relevant regulatory requirements and standards, including FDA, ISO, and CE. Prepare and review technical documentation to support regulatory submissions.
   • Produce and maintain quality system documentation, including design history files and device master records, per FDA QSR requirements.

EDUCATION REQUIREMENTS: MS in Mechanical Engineering, Electrical Engineering, or Biomedical Engineering.

EXPERIENCE REQUIREMENTS: 10+ years of experience as an R&D engineer in the medical device industry.

OTHER QUALIFICATIONS:

• Expertise in design for common medical device manufacturing methods, including injection molding, laser cutting, composite shaft construction, tight-tolerance machining, sheet metal fabrication, etc.
• Expertise in Solidworks CAD software and finite element analysis tools.
• Extensive experience in product development from a clinical to commercial phase.