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Design Assurance Engineer
2 months ago
Key Responsibilities 1. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements 2. Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. 3. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. 4. Support the verification, validation, and usability testing of changes to commercial designs to meet or exceed internal and external requirements 5. Develop Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints) 6. Create and maintain product risk management tools (i.e., Hazard Analysis, Fault Tree, FMEAs) 7. Support test method development and test method validation activities
Minimum qualifications: * Bachelors degree in Engineering discipline or related field of study * 2+ years of experience in design assurance, new product development, or related experience in a highly regulated industry * Working knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System Regulations * Effectively work and collaborate in a hybrid (onsite plus remote) environment Preferred
Qualifications: * Experience with design risk management (DFMEA, Hazard Analysis, etc) documentation * Experience with test method development and/or test method validation
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About Advantage TechnicalWith 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 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.
