Senior R&D Engineer

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. 

PURPOSE OF JOB: Create, prototype, and test medical devices, including components, assemblies, and products, using information supplied by engineering staff.

MAJOR DUTIES AND RESPONSIBILITIES:

• Have overall responsibility for design, sourcing, and documentation of subcomponents as specified by supervisor or project lead.
• Advise junior engineering team on documentation, prototypes, and product development
• Provide support in the resolution of product complaints and/or safety issues. 
• Ensure that processes/methods utilized are consistent with cost effective and reliable manufacturing practice. 
• Work with 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.
• Update supervisor/team of work status or problems with recommendations for improvement or correction. 
• Complete projects in a timely manner consistent with corporate objectives. 
• Maintain an accurate lab notebook and record of assignments and results including documentation concerning materials, parts used, concepts, designs, drawings, and processes. 
• Maintain current knowledge of medical, technical, and biomedical developments related to company’s products. 
• Provide feedback on product revisions or new products to project engineers and other company personnel as appropriate. 
• Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, and Quality Assurance functions. 
• Train assemblers when transferring processes or products. 
• Maintain a clean, safe, and well-organized work area.
• Develop and conduct laboratory testing protocols and document results. 
• Complete specialized studies or experiments culminating in written reports as needed. 
• Support company goals and objectives, policies and procedures, QSR, and FDA regulations.
• Use Solidworks to model and create designs. 
• Work from verbal, written, or pictorial information to create designs for engineering staff.  
• Document specifications and revisions, and maintain log of all work. 
• Verify all work, and document materials and quantities needed for products/components.
• Manage vendors and their schedules to obtain parts in a cost-effective and expedited manner.

EDUCATION REQUIREMENTS: BS in life sciences, engineering, or equivalent preferred.

OTHER QUALIFICATIONS: 

• 5+ years engineering experience, preferably in medical device development
• Experience with mechanical drawing, knowledge of Solidworks CAD software required.