Design Assurance Engineer

Industry

Engineering

Advert ID

FOX_BBBH167626

Location

Fridley

Job Type

Permanent

Hours

Full-Time

Salary Range

USD80000-127000 per year

No. of Openings

1

Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435

ContactNumber

612-630-1200

Job Description

Design Assurance Engineer III or Sr. Design Assurance Engineer | Direct Hire | $100-$127k + 10% Bonus | Fridley, MN





A well known medical device company is seeking a Design Assurance Engineer III or Sr. Design Assurance Engineer to help support large projects for medical devices that are complex parts and tight specifications and be a part of the Design Quality Team that's growing at a new R&D facility. This Engineer will have flexiblity, but mainly needs to be onsite.



* Represent Quality Assurance on product development teams, including developing Quality Plans and Risk Management Plans

* Support design and development project deliverables related to Design Controls, Risk Management, Design Verification and Validation to ensure meet applicable standards and regulatory requirements while ensuring a primary focus on patient safety and reliable product performance

* Design and/or specify inspection and testing procedures/systems to ensure products conform to specifications and quality standards

* Investigate/analyze customer complaints and support Regulatory Affairs to monitor customer complaint trends and maintain compliance to complaint system

* Support all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System.



Qualifications:



BS or MS: Mechanical or Biomedical Engineering (Engineering realm required)

5+ years as a Design Assurance Engineer

Medical Device industry experience (ISO 13485) required!