Mechanical Engineer

3 weeks ago


Pleasanton, United States Katalyst HealthCares & Life Sciences Full time

Responsibilities:

The Contractor Engineer Combination Products works with technical supervision on project teams in support of medical devices.

Activities include contributing to product design documentation and conducting laboratory studies of product performance in support of product development, manufacturing transfers and investigations and product enhancements.

Products are intended for electromechanical devices with integrated software. Work is conducted in compliance with device design controls (FDA 21CFR820.30 and/or ISO 13485) as applicable.

Special interest in candidates with mechanical design and drawing proficiency and execution and validation with emphasis on mechanical seal design.

Generate CAD data models and drawings.

Participate/lead prototype build of new designs.

Conduct independent laboratory work and data analysis

Place data in proper scientific context by consulting and citing relevant literature

Understand and adhere to corporate standards regarding code of conduct, safety, medical device design controls and GxP compliance.

Requirements:

Able to work in a regulated environment

Familiar with lab environment and safety practices.

Applies basic computer skills in support of data analysis

Proficient in mechanical design using Ceo or Solidworks and generating specification documents and drawings

Applies technical writing skills to produce technical reports and documents

Works under direction of senior staff

Summarizes and presents results of projects to project teams

Works in team environment

Collaborates with others on design and data analysis

Able to present work to small groups

Bachelors Degree or equivalent education in Mechanical or related field with 5+ years of experience (starting point

)

CAD experience, Creo or solid works

Plastic Design

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