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.

ESSENTIAL FUNCTIONS:

• Practices, mentors and develops company concepts, policies and procedures, familiar with and follows standard practices.
• Applies functional expertise at a level to make significant company contributions.
• Project goals are broadly defined; defines project milestones; responsible for timely project completion.
• Makes major contributions to strategic directions and projects through knowledge of technology and its creative applications.
• Drives activities for publication and/or patent potential.
• Conceives, plans, and executes projects related to the strategic needs of the company.
• Designs and executes experiments to test hypothesis related project outcomes; extracts the full relevance of technical observations.
• Applies advanced technical knowledge to multi-disciplinary projects.
• Assures experimental quality through sound experimental design; utilizes DOE; assists in the design of experiments for others.
• Participates or leads cross functional technical teams.
• Develops and maintains internal and external contacts to maintain technical knowledge.
• Trains and develops others using a variety of methods.
• Provides a technical role model to others.
• Advances the level of technical expertise within the company.
• Establishes project operation criteria and technical standards for excellence. 
• Presents results of projects both internally and externally.
• Reviews and critiques presentations for others.
• Consistently and effectively presents complex technical data to large and diverse groups.
• Monitors work to ensure quality, and continuously promote Quality First Time.