Principal Manufacturing Engineer

Zenflow, Inc. - San Francisco, CA

Full-time

MAJOR DUTIES AND RESPONSIBILITIES:

Design implant delivery system for improved manufacturability through part reduction, improved assembly techniques/fixturing in order to improve yields and labor content.

  • Design CMOS based imaging system for improved manufacturability through part reduction, improved assembly techniques/fixturing in order to improve yields and labor content.
  • Work with R & D engineers and vendors to implement product changes that result in reduced labor content as well as part count including easier methods to manufacture and assembly.
  • 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 competitive technologies in addition to medical, technical, and biomedical developments related to the company’s products.
  • Provide feedback on product revisions or new products to R & D 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.
  • 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.
  • Train assemblers when transferring processes or products in the Production.
  • Maintain a clean, safe, and well-organized work area.
  • Develop and conduct 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 and implement improvements for engineering staff.
  • Document specifications and revisions, and maintain a log of all work.
  • Verify all work, and document materials and quantities needed for products/components.
  • Manage vendors and their schedules to obtain parts and assemblies in a cost-effective and expedited manner.

EDUCATION REQUIREMENTS: BS Mechanical Engineering, or equivalent preferred.

EXPERIENCE REQUIREMENTS: Minimum seven years, preferably 10 to 15 years of related experience in the medical device industry.

OTHER QUALIFICATIONS: Experience with mechanical drawing, knowledge of relevant CAD software required as well as injection molding and typical assembly methods for disposable medical devices. Must have advanced design skills and working knowledge of catheter assembly techniques/technologies. Experience scaling up products into Pilot or Production environments.

Job Type: Full-time

Salary: $130,000.00 to $170,000.00 /year

Experience:

  • Manufacturing Engineering: 8 years (Preferred)

Education:

  • Bachelor's (Preferred)