Design Quality Assurance Engineer

Duration: 12 Months Contract (Possible Extension)About Job Opportunity:HybridThe Design Assurance Engineer will interface with R&D and other supporting cross-functional teams on developing and maintaining medical equipment, including software and cybersecurity elements.Design assurance drives the ISO 14971 risk management process, 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.Interfaces with all other quality and engineering components within the company and with customers and suppliers on quality-related issues.Actively participate in all aspects of Design Control, including capital equipment, systems, and software. Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities.Key ResponsibilitiesSupport the execution and documentation of Design Validation & Verification and Usability activities.Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).Lead and support cross-functional root-cause analysis investigation and resolution activitiesEvaluate and support design test and inspection method development, and lead method validation activitiesSupport regulatory submissions to notified bodies.Understanding of technologies incorporated into design.Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.Minimum QualificationsBachelor's degree in Mechanical Engineering, Biomedical Engineering or Electrical Engineering.2+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experienceProblem solver, capable of facilitating the problem-solving processAdaptable and effective collaborator in a team environment and in self-directed workStrong communication skills (verbal & written)Ability to work in a highly matrixed and geographically diverse business environmentDemonstrated use of Quality tools/methodologiesPreferred qualifications:Previous Software or Capital equipment Design Assurance experience is a plusMedical device or other regulated industry experienceStrong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)Experience with 60601, software and cybersecurityExperience working in an Agile environmentAbout 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 learn more about US Tech Solutions, please visit .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.Name: Kanika DurejaEmail: kanika.d@Internal Id: 25-32258

Created: 2025-02-20