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 propsopentheurethra, 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:
- 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 design
- 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
- 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, orBiomedical 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
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