About the job

The Senior Mechanical Engineer has a proven track record of developing medical devices and bringing them to market.  This individual is a mentor and provides technical oversight to other members of the department. This is a key contributor and subject matter expert in the design and development of medical diagnostic devices. This individual will excel in a dynamic and exciting workplace environment. 

How you’ll make an impact

• Design and develop parts and modules and the creation of novel diagnostic molecular test products.
• Define design requirements, specifications, and drawings to ensure product function.
• Transfer design to manufacturing and vendor selection to support high-volume scale-up. 
• Lead contributor during the design development process, providing input to Design History File (DHF), and leading informal and formal design reviews.
• Perform or provide technical oversight to others to perform experiments to verify mechanical and/or assay performance.
• Possesses a thorough understanding of all precedents, practices, and principles behind the operation of diagnostic devices.
• Research through concept development, prototype, or analysis designs or methods for future products.
• Performing necessary analysis to ensure proper product function. Finite Element Analysis (FEA), tolerance stacks, etc.
• Contribute to grant writing activities.
• Write patent disclosures.
• Mentors and provides technical oversight to more junior members of the department.
• Other duties as assigned

On your first day we’d like you to have

• AS in Bioengineering or Mechanical Engineering or related degree with 10+ years of experience; BS in Bioengineering or Mechanical Engineering with 7+ years of experience; MS in Bioengineering or Mechanical Engineering with 5+ years of experience.
• Extensive experience in the design of precision injection molded components and elastomers for high-volume and low-cost production of medical devices.
• Experience with products that perform precise fluid handling.

It’s great if you have

• Expert mechanical designer using Solidworks. 3D and 2D. GD&T ASME Y 14.5M - 1994.
• Knowledge of design control process for the development of class 2 medical devices.
• Test method development and validation.
• Excellent communicator, verbal and written.
• Demonstrated ability to work effectively under pressure, while maintaining the highest ethical. 
• Demonstrated ability to hold the highest ethical standards, serving as a role model both within and outside of the company.

Unique aspects of this job

• Schedule: This role is expected to be onsite Monday to Friday.
• Physical aspects:  Standing, sitting, walking, repetitive movement, safe chemicals handling, safe lifting, etc.

Salary Range:

• $125,000 - $152,000 (salary range for candidates based in San Jose, CA)
• Compensation for the role is based on geographical location. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly.
• Compensation also depends on a number of factors including a candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown.