Actively promote and participate in a cross-functional teamwork environment. Independently make decisions and work without constant supervision. Prioritizing tasks and projects, without direct oversight. Supervise up to 5 direct reports (engineers and/or technicians) in design quality including assignment and operational oversight of small to medium projects within the sustaining organization. Supervise others in the creation of 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 Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables. Bachelor's degree in engineering or science discipline, or equivalent. Minimum of 5 years of experience in design assurance, R&D, or related medical device or regulated industry experience Strong communication skills (verbal & written) and presentation skills Problem solver, capable of facilitating the problem-solving process & driving issues to closure Excellent organizational and planning skills; drives for results 1+ years of direct or indirect supervisory experience Travel approximately <10% ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis Previous development and design of testing and/or automated equipment Previous experience with Measurements System Analysis Previous experience with Regulatory testing in Medical Device or Regulated Industry
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