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Senior Mechanical Engineer

San Jose, CA · Manufacturing

Visa Sponsorship Permitted
Full Relocation Assistance offered

We are seeking an exceptional Senior Mechanical Engineer to design, develop, and validate semi or fully automated equipment that is used for the scale-up of high volume, disposable devices. Your role is to find creative and sound engineering solutions to challenging problems with a strong focus on quality, reliability, and execution. This is a hands-on position that requires interaction and collaboration with a cross-functional team including Engineering, Manufacturing, Biology, Quality, Facilities, and Sustaining.

Requirements

  • Develop concepts and ideas for improving existing tooling as well as creating new tooling including semi-automation where applicable
  • Evaluate the current manufacturing processes & workflows, identify opportunities for improved performance/throughput by applying knowledge of product design, fabrication, assembly, tooling, and materials as well as soliciting feedback from operators
  • Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch, and documentation
  • Create 3D models, engineering drawings and bills of materials
  • Create comprehensive work instructions and manufacturing SOP’s
  • Create verification/validation protocols (IQ,OQ,PQ), lead/support the execution activities, generate relevant data and provide corresponding documentation and reports
  • Participate in design FMEA and plan steps for mitigating risks
  • Establish a working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Requirements

  • Bachelor's Degree in Mechanical Engineering
  • 5-7 years hands-on, relevant experience
  • In-depth experience with complex mechanical/electromechanical design
  • Extensive experience with precision mechanisms, pneumatics, servo systems, tooling/fixtures, and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
  • Experience with creating engineering drawings, BOMs and product specifications
  • Deep knowledge of material properties, heat treatment, and surface finish
  • Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP, and QMS standards
  • Good understanding of DFM and lean manufacturing
  • Excellent verbal, written, presentation and interpersonal skills
  • Strong analytical and problem-solving skills
  • Knowledge and/or hands-on experience with machine shop tools
  • Deep knowledge of GD&T as well as proficiency with SolidWorks
  • Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

  • Master’s degree in Mechanical Engineering or equivalent
  • Knowledge/experience with plastic injection molding
  • Knowledge/experience with DOE, SPC, JMP /Minitab
  • Experience with metal stamping, laser cutting and chemical etching
  • Familiarity with and sterilization process and aseptic environment
  • PLC programming

Travel

Up to 10%

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