TargetCW - Corporate

Medical Device Engineer III

Job Locations US-CA-Mountain View
Job ID 2021-6976
Category
Engineering
Type
Contract

Overview

Title:  Medical Device Engineer III

Location: Mountain View, CA (Hybrid – in office and remote)

Term: 6-month contract (potential for extension and/or conversion)

Pay: $120,000/ year (Weekly pay)

Full-time M-F

Benefits: Medical/Dental/Vision

 

Responsibilities

  • Establish and maintain design history file documentation for development projects (design and development plan, requirements specifications, device master record, IOV matrix, verification and validation summary reports, etc.)
  • Establish and maintain risk management documentation (risk management plan, hazards analyses, failure mode and effects analyses) for development projects in accordance with ISO 14971
  • Coordinate product testing with vendors (e.g., mechanical shock and vibration, environmental conditioning, ISTA 3A, battery tests, IP22, etc.), including protocol development, sample coordination and writing test reports.
  • Review deliverables from vendors, such as technical drawings, technical reports, etc.
  • Generate and maintain technical specifications for product components
  • Coordinate activities required to get parts & suppliers added to ASL
  • Generate technical protocols and reports
  • Develop validation master plans, IQ/OQ/PQ protocols and reports for test fixtures and manufacturing equipment

Skills Required

  • Excellent mechanical aptitude and good attention to details
  • Experience designing and troubleshooting electronic and mechanical systems
  • Experience with CAD software (SolidWorks) including preparation of engineering drawings using GD&T preferred
  • Experience in designing injection molded parts preferred
  • Excellent oral and written communication skills as well as strong interpersonal skills
  • Experience programming in LabVIEW a plus
  • Well versed in FDA regulations for medical devices and products including Design Controls 21 CFR 820 and MDR
  • Experience working in compliance with GMP regulations

 

Education and Experience

  • Bachelor’s or higher-level STEM degree, Physics or related field, or demonstrated equivalent experience
  • 5+ years’ product development experience in medical device

 

Please submit your resume for consideration!

#8

"TargetCW is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation."

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