Intellectt Inc | Development Quality Engineer | saint paul, mn

7 days ago


saint paul, United States Intellectt Inc Full time

Job Title: Sr. Development Quality Engineer

Location: Saint Paul, MN

Duration: 12 Months


Job Description:

Additional duties may be identified by functional management based on current project/business objectives:

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and
  • cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.


Required Qualifications:

  • Bachelor’s degree within an Engineering field or a closely related discipline.
  • Medical device engineering experience and demonstrated use of Quality tools/methodologies.


Preferred Qualifications:

  • Bachelor’s or advanced degree in Mechanical or Biomedical Engineering
  • Prior experience with Cardiovascular medical devices
  • Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
  • Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Multitasks, prioritizes, and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel occasionally (


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