Quality Engineer I

1 month ago

Maple Grove, Minnesota, United States Advantage Technical Full time

Quality Engineer I

Hybrid position - 3 days onsite

Job Purpose

The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. Employee will work with high-performance cross-functional team to ensure safety, quality and compliance throughout new product development. This position will focus on establishing robust risk management, test method development, and design verification planning/testing through the new product development process.

This person will be working with a Design Assurance team of 8-9 people, including manager, on a very highly new product development.

Your responsibilities include:

  • Actively promote and participate in a cross-functional teamwork environment
  • Develops understanding of Design Controls, Risk Management and Usability for Medical Devices
  • Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling)
  • Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Successfully complete engineering work in one or more of the following: test method validation, risk management, bench and verification testing
  • Support development and coordinate the execution of Design Validation and Verification activities
  • Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Support the verification, validation, and usability testing to meet or exceed internal and external requirements
  • Perform regulatory standard assessments and support regulatory submissions to notified bodies
  • Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)

Minimum qualifications:

  • Bachelor's degree in mechanical, electrical, or biomedical engineering, or equivalent
  • 0-1 year of experience

Preferred Qualifications:

  • Focus on detailed work with emphasis on accuracy and completeness
  • Excellent organizational and planning skills; drives for results
  • Strong communication (oral and written) and presentation skills
  • Medical Device Experience
  • Ability to collaborate on a cross-functional team

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About Advantage Technical

With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

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