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Manager, Mechanical Engineering

4 months ago


San Diego, United States Cypress HCM Full time
Job DescriptionJob DescriptionManager, Mechanical Engineering
Summary:
  • Experience with developing products from concept through validation and manufacturing.
  • Understanding of regulatory requirements such as FDA cGMP, ISO, CE.
  • Develop mechanical designs that meet both internal and external customer needs.
  • Interface with outside vendors as needed to communicate design requirements and databases to ensure the accuracy of parts and subsystem manufacturing by vendors.
  • Perform troubleshooting and problem-solving efforts related to the development projects.
  • Support decisions through engineering and analysis data.
  • Generation of product development documentation: requirements, plans, specifications & drawings, procedures (test, manufacturing and QC), reports, design reviews and validation.
  • Injection molding, machined components, fabrication and assembly methods.
  • Manufacturing processes and fixture design for reliability.
  • Experience with prototyping methods and processes.
  • Proficient with design systems; Solid Works, Pro E, AutoCAD, etc.
  • Experience working with contract manufacturers.
  • Manufacturing support for production, QC, and investigations.
  • Excellent teamwork, written and verbal communication skills required.
  • Lead and support sterilization technology projects for high volume medical device products.
  • Demonstrate hands-on technical understanding and provide guidance and training to junior engineers and technicians on test methods and data analysis techniques.
  • Drive operational excellence strategies to reduce cost and increase efficiency through product packaging design, process, and manufacturing changes.
  • Develop manufacturing processes and equipment with the Manufacturing Engineering team.
  • Organize and lead frequent technical reviews.
  • Create assemblies and components using SolidWorks.
  • Perform tolerance analysis calculations and studies.
  • Work with project managers on design input requirements.
  • Assist regulatory with FDA related questions on submissions.
  • Participate in the change control process for review and generation of change orders.
  • Work with project managers on DFMEA.
  • Lead Mechanical and other V&V activities, such as writing and executing verification protocols and reports as required.
  • Support Quality System Technical Compliance with participation in Material Review Board, Non-Conforming Material Investigations and Corrective and Preventative Action (CAPA) activities.
  • Participate in design reviews.
  • Complete other engineering duties as required by business needs.
Requirements:
  • B.S. degree in Mechanical Engineering or a closely related field.
  • Minimum 8 years of related engineering experience. 3 years of managing projects with cross functional interactions.
  • Thorough understanding of ISO13485 quality control and documentation or equivalent standards from other regulated industries.
  • Proficiency in SolidWorks and GD&T (Geometric Dimensioning and Tolerancing).
  • Proficiency with standard Microsoft Office tools.
  • Expert knowledge of mechanical technical principles, theories and concepts.
  • Ability to use common tools in machine shop.
  • Excellent written and oral communication skills.
  • Proven professional qualities including strong initiative, integrity, and the desire / ability to work in a team environment.
  • Ability to organize and manage multiple projects simultaneously.

Pay Rate: $70 - $85 per hour