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Design Assurance Engineer I
2 months ago
Duration: 06+ Months Contract (Possible Extension) Duties: Hybrid – Three Days in office. 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. FIRM. 1+ years of experience Preferred Qualifications: Focus on detailed work with an 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 About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: Kanika Email: kanika.d@ustechsolutionsinc.com Internal Id: 24-18327
