Mechanical Engineer
Specific Diagnostics: San Jose, California, United States (On-site)
The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. The sepsis mortality rate increases >6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.
Specific Diagnostics has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for the bloodstream and other acute infections. Used for bloodstream infection Specific’s solution provides results 2 days sooner (1 day vs 3 days).
We have been funded by nearly $30 M in non-dilutive government-sponsored research support and recently $17.5 M in venture capital. This is an opportunity to join us at an inflection point in our commercial growth as we bring our first key product to market and with recognition from major customers fueling an expansion of our staff.
The Job
Mechanical development is not a small matter here. The mechanical aspects of Specific’s medical instruments are critical to our success. Great mechanical engineering is part of our company DNA. You will be responsible for designing the mechanical components of our products to meet the challenging function and manufacturability goals.
You will work closely with our brilliant scientists (chemists and microbiologists) and our talented engineers. You will also interact with machine shops, tooling vendors, and other design and manufacturing partners. You will not be designing one part in one product, rather you will be involved in a wide variety of design tasks and concurrent design programs.
The mechanical design challenges include:
• Design and engineer, electro-mechanical systems, mechanisms, and manufacturing fixturing.
• Conceptualize, create and document detailed mechanical designs.
• Develop stable, robust machined parts.
• Assure ease of manufacturability, assembly, and service.
• Creating detailed drawings and assisting in the management of assembly instructions, bills of materials, inventory control, material procurement, and component sourcing.
• Lives depend on the products we make so quality is a must. We are ISO-13485 certified and have a well-run quality management system. A critical aspect of the role is assuring quality design and verification testing.
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You will be working interactively with senior engineers, chemists, microbiologists, for the successful delivery of products. You will follow up your design with unit testing, product quality, and regulatory testing ensuring a reliable, manufacturable, and robust product.
You
Creating new to the world, impactful products requires passion, smarts, strength, persistence, and hard work. You are a self-starter who can work effectively with others in a small high-energy team focused on results and hitting deadlines. It is important that you be comfortable and capable with the environment and responsibilities of a small, fast-moving company. You will need to be hands-on closely involved in all aspects of design, prototyping, test, documentation, and manufacturing.
You should have a track record of success and have these characteristics and skills:
• Bachelor’s Degree and 5 years experience in mechanical engineering.
• Expertise with Solidworks: modeling, documentation, simulation, FEA, PDM.
• Experience in Medical devices or instruments and the requirements of quality management systems and documentation required for Medical instrument development.
• Ability to manage multiple tasks and projects.
• Superior creativity and resourcefulness to deliver final products under tight deadlines.
• Experience in machine design for automation (linear, rotary, cyclic, etc).
• Work closely with cross-disciplinary teams
• Excellent written and verbal communication skills.
• Applicants must have U.S. employment authorization