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Senior Mechanical Engineer - R & D

Incubelabs San Jose ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Job Title: Senior Mechanical Engineer R & D

Job Summary

The Senior Mechanical Engineer is responsible for evaluating and improving the current drug delivery system while maintaining high quality and reliability standards.  This will be achieved by testing the system and optimizing components or subassemblies as needed. In addition, he/she will be required to work with quality and regulatory to develop complete documentation for the device. The successful candidate will work independently and use sound judgment to deliver optimal solutions. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

 

Responsibilities

  • Evaluate the current design and identify opportunities to realize improvement in product consistency and increased throughput in a manufacturing environment
  • Show proof of concept through prototyping and supporting test data, and coordinate implementation with appropriate stakeholders
  • Take full ownership of documentation by following internal design control SOPs, leading verification/validation activities, and participating in phase reviews
  • Create 3D models, engineering drawings and bill of materials
  • Create comprehensive work instructions and manufacturing SOP’s
  • Work with quality to resolve any issues with components or processes
  • Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
  • Comply with company’s policies and guidelines regarding quality and regulatory

 

Qualifications

  • Bachelor's Degree in Mechanical Engineering
  • 5 plus years hands-on experience in a design environment
  • Experience with creating engineering drawings, BOMs, and product specifications
  • In-depth experience with complex mechanical  systems that interact with biology
  • Prior experience in a medical device company
  • Experience with design control process for medical devices and implementation of product in to manufacturing
  • Working knowledge of FDA regulations and ISO, cGMP, 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
  • Proficiency with SolidWorks required
  • Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

 

Preferred Qualifications

  • Knowledge /experience with plastic injection molding
  • Masters’ degree or higher in Mechanical Engineering or Biomedical Engineering

 

Travel

Up to 10%

Incubelabs

Address

San Jose, CA
95112 USA