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Senior Engineer, Design Assurance in Skaneateles Falls, NY at Integrated Resources, Inc

Date Posted: 1/7/2019

Job Snapshot

Job Description

Position: Senior Engineer, Design Assurance Location: Skaneateles Falls, NY Salary Grade: 60 Position Overview: As a Senior Engineer, Design Assurance, you will ensure the establishment and execution of world-class Design Control processes that deliver safe and reliable products, while also enabling speed to market. You will partner with the sustaining engineering team in the design maintenance of FDA Class I and Class II medical devices to ensure that design control principles are followed, and that safety and efficacy is demonstrated. At all times throughout the process, you will identify and mitigate risks. Key Responsibilities: Provide quality assurance support and oversight for product design activities including: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes. Ensure compilation and maintenance of product Design History Files. Partner with Design Engineering to ensure design reviews are thorough and robust. Review and approve Design Verification and Validation test plans, protocols and reports; guide the use of robust statistical techniques. Document traceability of requirements through design output and to design verification and/or design validation. Insist on early requirements maturation, early test plan/script development, and design input requirements that are indicative of real world use case environment and customer needs. Review intended use validation for non-product software and tools used in the development process. Actively participate with design teams on developing product Risk Management Files; ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards. Perform DHF audits of other products as an independent reviewer. Support external regulatory and customer audits. Collaborate with global Design Assurance team to drive continuous improvement, including development of standard work, striving for a world-class Product Development Process. Required Background and Competencies: Bachelor s Degree in engineering or related field 5+ years experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense) Experience with development of electromechanical systems is required. Experience with software development processes is a plus. Strong working knowledge of design controls as required by FDA 21 CFR 820.30, European Medical Device Regulation and ISO 13485 product realization. Knowledge of Quality Management Systems beyond design control compliant with FDA 21 CFR 820 and ISO 13485, product safety standards (e.g., IEC and ANSI/AAMI), Human Factors/Usability Engineering, statistical analysis methods, ISO 14971 Risk Management and cybersecurity controls are a plus. ASQ or related quality certification is preferred. Detail oriented with strong organizational and record keeping skills Problem solving and root cause analysis skills Systems Engineering knowledge, experience with complex multifunctional systems Ability to facilitate cross-functional team meetings. Strong written and oral communications skills using English language; ability to succinctly and clearly describe complex issues in meaningful ways. Ability to engage different functions in meaningful discussions and maintain enthusiasm for efforts. Proactive and timely in execution of assigned tasks Ability to be flexible and adaptable to changing priorities