Senior Mechanical Engineer

5 days ago


Pleasanton, California, United States Prokatchers Full time
Job Title: Senior Mechanical Engineer

Job Summary:

Prokatchers is seeking a highly skilled Senior Mechanical Engineer to join our team. As a Senior Mechanical Engineer, you will be responsible for designing, developing, and testing complex mechanical systems for class II and class III medical devices.

Key Responsibilities:

  • Design and develop electromechanical devices for VAD and CPB applications
  • Work with cross-functional teams to develop new products and improve existing products
  • Establish requirements and specifications for products
  • Use experimental, empirical, and numerical analysis to evaluate designs
  • Develop and qualify fixtures/equipment for verification testing
  • Investigate issues and identify root causes in complex systems
  • Identify and mitigate technical risks and program risks
  • Create/review technical drawings for assembly, dimensioning, and tolerancing
  • Support projects in various capacities
  • Maintain a detailed understanding of the developing clinical environment
  • Provide input and support to Regulatory Affairs for FDA/global regulatory submissions
  • Aid in vendor evaluations
  • Comply with FDA regulations and Company policies

Requirements:

  • B.S. in Mechanical, Biomedical, or Manufacturing Engineering
  • 6-8 years engineering experience in product development, process development, risk assessment, and V&V verification related to class II/III medical devices
  • Industry experience with FDA design controls 21 CFR 820.30
  • Strong communication and presentation skills
  • Ability to travel approximately 10%

Preferred Qualifications:

  • Design and V&V of class II/III electromechanical medical devices
  • Experience with medium to high volume medical device manufacturing
  • Experience with a variety of manufacturing processes and designing for manufacturability
  • Industry experience with EU MDR, ISO 13485, and standards for medical devices
  • Experience with CAD design, SPC/six sigma, DOE, and project management


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