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 Senior R&D Mechanical Engineer will play a critical role in the design, development, and testing of innovative medical devices from concept through commercialization. The ideal candidate has a strong background in mechanical engineering, extensive experience in medical device development, and a passion for solving complex engineering challenges.
MAJOR DUTIES AND RESPONSIBILITIES:
- Innovation and Problem Solving
- Develop innovative solutions to challenging engineering problems
- Maintain current knowledge of medical, technical, and biomedical developments related to the company’s products.
- Mechanical Design and Analysis
- Use Solidworks to create detailed designs and drawings
- Have overall responsibility for design, sourcing, and documentation of subcomponents and subassemblies for new products or product revisions.
- Prototyping, Testing, and Documentation
- Work with other engineers, machinists, and physicians to create working prototypes, specifications, and drawings for new products or product revisions which are low-cost and easy to manufacture.
- Conduct Verification/Validation activities, including product specification and test method development
- Maintain an accurate lab notebook and record of assignments and results
- Vendor Management
- Manage vendors and their schedules to obtain parts in a cost-effective and expedited manner
- Mentorship
- Advise junior engineering team on documentation, prototypes, and product development
- 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
EDUCATION REQUIREMENTS: BS in Mechanical Engineering, Electrical Engineering, orBiomedical engineering.
EXPERIENCE REQUIREMENTS: 6+ years of experience as an R&D engineer in the medical device industry.
OTHER QUALIFICATIONS:
- Experience in designing injection-molded components
- Extensive experience with mechanical drawing and Solidworks
Powered by JazzHR
HBThpaH8AY
