Senior R&D Engineer

Zenflow, Inc.; San Francisco (CA); On-site; USD 80,000 - 130,000; Full time

Job summary

Join a pioneering medical device company as a Senior R&D Mechanical Engineer, where you'll be at the forefront of innovation in medical technology. This role involves designing and developing cutting-edge devices that improve patient care, particularly for urinary obstruction issues. You'll leverage your mechanical engineering expertise to create prototypes, conduct thorough testing, and ensure compliance with regulatory standards. Collaborate with a talented team of engineers and medical professionals to solve complex challenges and bring life-changing products to market. If you're passionate about making a difference in healthcare through engineering, this opportunity is perfect for you.

Qualifications

• 6+ years of experience in R&D engineering within the medical device industry.
• Strong background in mechanical engineering and problem-solving.

Responsibilities

• Develop innovative solutions and maintain knowledge of medical developments.
• Ensure designs meet regulatory requirements and manage vendor schedules.

Skills

Mechanical Engineering

Medical Device Development

Problem Solving

Solidworks

Prototyping

Regulatory Compliance

Education

BS in Mechanical Engineering

BS in Electrical Engineering

BS in Biomedical Engineering

Tools

Solidworks

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: 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:

1. Innovation and Problem Solving
   1. Develop innovative solutions to challenging engineering problems.
   2. Maintain current knowledge of medical, technical, and biomedical developments related to the company’s products.
2. Mechanical Design and Analysis
   1. Use Solidworks to create detailed designs and drawings.
   2. Have overall responsibility for design, sourcing, and documentation of subcomponents and subassemblies for new products or product revisions.
3. Prototyping, Testing, and Documentation
   1. 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.
   2. Conduct Verification/Validation activities, including product specification and test method development.
   3. Maintain an accurate lab notebook and record of assignments and results.
4. Vendor Management
   1. Manage vendors and their schedules to obtain parts in a cost-effective and expedited manner.
5. Mentorship
   1. Advise junior engineering team on documentation, prototypes, and product development.
6. Regulatory Compliance
   1. 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, or Biomedical 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.