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Design Assurance Engineer
3 months ago
We are seeking a highly motivated Design Assurance engineer for our Global Medical Device client.
About the role:
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 sustaining team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life.
This position will focus on test method and equipment development to satisfy product requirements.Your responsibilities include:
- Actively promote and participate in a cross-functional teamwork environment.
- Develop test equipment to satisfy product requirements for design verification from concept to functional equipment.
- Write various technical documentation for procedure execution, technical rationale and evidence of the development process.
- 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
- Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
- Understanding human anatomy and physiology and be able to apply that knowledge to the usage of medical devices.
- Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables.
Minimum qualifications:
- Bachelors degree in biomedical or mechanical engineering or related field of study
- 3+ years of experience in design assurance, new product development or related medical device / regulated industry experience
- Hands-on approach to product development
- Experience using SolidWorks 3D Modeling Software or equivalent
- Strong communication skills (verbal & written)
- Demonstrated use of Quality tools/methodologies
- ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
- Previous development of testing and/or automated equipment
- Previous experience with Measurements System Analysis
- Experience integrating data acquisition equipment and clinically relevant simulated environments
- Experience using Minitab statistical software
- Experience using Matlab programming language
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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 visitAdvantage 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.
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.
