Hybrid Quality Design Assurance Engineer
Maple Grove, MN 
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Posted 3 days ago
Job Description
We are seeking a Quality Design Assurance Engineer with previous Medical Device experience to work for our client a leader in Medical Device Technology. This is a contract to hire positions and is hybrid.

This role will work within high-performance, cross-functional teams to ensure safety, quality, and compliance of commercialized products while continuously improving their value through end-of-life.
Design Assurance drives the ISO 14971 risk management process and the Verification & Validation (V&V) process.
This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports.
This role will be responsible for ensuring quality and compliance through product development and commercialization for medical electrical equipment/systems

Bachelors degree in biomedical, Mechanical, or Electrical Engineering, or related field of study
* Plus 2+ years of experience in design assurance, new product development, or related experience in a highly regulated industry
* Demonstrated use of Quality tools/methodologies
* Strong verbal and written communication skills * Self-motivated with a passion for solving problems and a bias for action
* Effectively work and collaborate in a hybrid (onsite plus remote) environment Preferred qualifications:
* Prior medical device industry experience, particularly with medical electrical equipment * Working knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System Regulations

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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 AdvantageTechnical.com.

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.

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.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Salary and Benefits
$45.00-$45.00
Required Education
Bachelor's Degree
Required Experience
2+ years
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