Applies intensive and diversified knowledge of design principles, practices and implementation in complex systems and assignments. Defines Quality and Regulatory strategies for complex diagnostic systems in development and provides guidance to Quality Engineering team and product development teams. Ensures mechanical, electrical, and software for complex diagnostic systems is compliant with regularity standards and intended purpose.
General responsibilities include participating in design and development reviews, and testing to assess performance against design specification; reliability testing, and assessment of system interactions.
Maintains extensive knowledge of principles, theories, and practices in Design for Excellence activities such as Design for Manufacturability for complex diagnostic systems to include software and hardware. Provides technical knowledge of Design and engineering principles and their application to ensure that cost-effective, reliable and high-quality systems that satisfy customer needs and business requirements are delivered.
Provide Quality leadership for entire product life cycle support, identify/implement continuous improvement initiatives, develop/propose compliant strategies to meet current and future regulatory requirements. Provides Quality strategic business partnership with Life Cycle Teams and key stakeholders by building effective relationships, proactively ensuring two-way communication, ensuring alignment of Business and Quality goals, effectively managing conflicts and trade-off decisions, developing and implementing compliant solutions to achieve business objectives.
MINIMUM QUALIFICATIONS:Formal Training/Education:
BS degree or equivalent in a directly related discipline.
Requires a minimum of 12 years of related experience OR MS degree in directly related discipline + 8 years of related experience required; OR, PhD in directlyrelated discipline + 6 years of related experience required.