Medical Device Engineer II Job at Gateway Recruiting, INC., Mountain View, CA

bGhqU3E3cHBMSTR3MkYxYmZNd2ZmaEwySnc9PQ==
  • Gateway Recruiting, INC.
  • Mountain View, CA

Job Description

Job Description

Job Description

Responsibilities:

  • Establish and maintain design history file documentation for development projects (design and development plan, requirements specifications, device master record, IOV matrix, verification, 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 technical protocols and reports
  • Develop validation master plans, IQ/OQ/PQ protocols, and reports for test fixtures and manufacturing equipment
  • Review mechanical drawings and electrical schematics

Skills Required:

  • Excellent technical writing skills
  • Excellent mechanical aptitude and good attention to detail
  • Excellent oral and written communication skills as well as strong interpersonal skills
  • 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
  • Experience with mechanical drawings and electrical schematics preferred

Education and Experience:

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

Physical Requirements:

  • Prolonged periods of sitting at a desk and working on a computer
  • Must be able to lift up to 15 pounds at times
  • Must be willing to travel

Powered by JazzHR

gEWKW1NF1V

Job Tags

Similar Jobs

Rise Corporate, LLC

Speech Language Pathologist Assistant Job at Rise Corporate, LLC

Clinic - Pediatric Speech Language Pathologist Assistant (SLPA)MedCare Pediatric Group is looking for a passionate Speech Language Pathologist Assistant (SLPA) to join our growing team to provide, evaluate, and implement speech therapy services to pediatric clients... 

KVK Tech

HR Coordinator/Recruiter - Entry Level Job at KVK Tech

 ...interview, and recommended candidates for various departments and levels Manage the staffing process by posting open positions,...  ...Leadership skills which reflect directives for compliance of all pharmaceutical products Innovative Naturally positive, upbeat attitude... 

HOPE HOME CARE

Registered Nurse RN / Licensed Practical Nurse LPN - Home Care Nursing *$1,000 Bonus!* Job at HOPE HOME CARE

Hope Home Care, Inc. is a home care agency with almost 40 years of experience connecting...  ...a schedule that revolves around you. _*LPN Pay Rate - $33/hr*__*RN Pay Rate - $43/hr...  ...including direct nursing care in the areas of health maintenance, nutrition, activities of... 

Omnicom Health Group

Senior Medical Editor Job at Omnicom Health Group

 ...This is one of the many things that make Omnicom Health Group the Freelancers Network of Choice.Title : Freelance Senior Medical EditorLocation : New York, NYDepartment/Discipline : EditorialOverview:Freelance Senior Medical Editors review concepts, manuscripts... 

Creative Financial Staffing

Payroll and Human Resources Assistant NY Job at Creative Financial Staffing

 ...Payroll & HR Assistant CFS is working with a charter school that teaches based on inquiry, active and experiential learning, and social justice. The accountant will report to the CFO, and is responsible for accounts payable, cash receipts, and the management of financial...