JOB FUNCTION: Scientific
JOB TYPE: Direct Hire
LOCATION: Branchburg, NJ

MINIMUM EDUCATION: Bachelor's Degree
POSTED: Aug 13, 2019

Our client is a multinational manufacturer of medical devices, looking to hire a Product Development Engineer.

Salary/Rate: DOE

Position Overview: The Product Development Engineer is focused on ensuring that product designs meet all specifications and regulations regarding the FDA, as well as supporting documentation for 510(k) submission.

Responsibilities of the Product Development Engineer:

  • Supporting the entire process of new product development or transferring into new markets
  • Ensuring that designs are compliant with safety standards and FDA guidelines
  • Assist in creation of protocols and technical reports regarding safety and performance
  • Ensuring accuracy of documentation regarding standards such as 21 CFR, ISO, IEC, etc for 510(k) submissions
  • Assessing risk and ensuring that required testing has been completed
  • Coordinating critical project activities to ensure completion based on timelines
  • Scheduling development milestones as well as planning projects for new product realization
  • Improving upon existing processes in product development
  • Performing other duties as necessary

Qualifications for the Product Development Engineer:

  • 7+ years of experience in quality/regulatory and product development, specifically in medical devices
  • Strong interpersonal skills, as well as verbal and written communication skills
  • Strong organization skills and attention to detail
  • Successful experience with project management
  • Ability to travel up to 20%

Education Requirements:

  • BS in Biomedical engineering or related field

Benefits: DOE


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