Job Description
Length of Contract: 6 months- Possible extension
Work Schedule: Monday to Friday regular business hours 8-5
Description Details
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.
Primary Function / Primary Goals / Objectives:
• 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.
Level of Expertise:
• 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
Level of Leadership Activities:
• Works under direction of senior staff
• Summarizes and presents results of projects to project teams
Level of Interpersonal Skill:
• Works in team environment
• Collaborates with others on design and data analysis
• Able to present work to small groups
• Years of experience/education and/or certifications required: Bachelors Degree or equivalent education in Mechanical or related field with 5+ years of experience (starting point)
• What are the top 3-5 skills requirements should this person have?
CAD experience, Creo or solid works
Plastic Design
Tolerence analysis for dimensioning, product design prototyping and testing experience