Lead Medical Device Product Developer

5 days ago


South San Francisco, California, United States Zenflow Full time

About the Role

Zenflow, Inc. is a medical device company focused on improving treatment for patients suffering from urinary obstruction caused by an enlarged prostate.

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.

Key Responsibilities
  • Technical Leadership: Provide technical direction and oversight throughout the product development lifecycle.
  • Innovation and Problem Solving: Concept ideation and brainstorming based on known customer requirements and manufacturing scalability challenges. Develop innovative solutions to challenging engineering problems.
  • 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.
  • Collaboration and Communication: Collaborate cross-functionally with clinical, regulatory, and manufacturing teams to ensure alignment and integration of technical requirements.
  • Mentorship: Mentor and develop junior engineers, fostering a culture of continuous learning and innovation.
  • 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.

Requirements

MS in Mechanical Engineering, Electrical Engineering, or Biomedical Engineering. 10+ years of experience as an R&D engineer in the medical device industry.

Expertise:

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

Estimated Salary Range:$150,000 - $180,000 per annum.


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