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Senior Mechanical Engineer – Medical Device

San Jose, CA · Biotech/Pharmaceutical
Title: Senior Mechanical Engineer – Medical Device
Location: San Jose, CA
Relocation Assistance: Yes
 
 
Excellent opportunity for an experienced 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. As the Senior Mechanical Engineer, 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.
 
  • 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, Master’s preferred
  • 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
  • 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
 
 
Thank you for your interest in the Senior Mechanical Engineer – Medical Device position.  A brief cover letter outlining your relevant experience is kindly requested. Applicants that meet the client’s qualifications will be contacted; all other candidates will be retained for future opportunities




 
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