Senior Design Project Engineer, Quality (35556)

Responsibilities

• Creates and assists in developing, maintaining, and improving the Quality Management System (QMS) to ensure compliance to all specified regulatory agencies.
• Drives product quality improvements internally and externally by working with design, manufacturing, and supply chain.
• Acts as a technical lead, manages significant systems, uses strategic planning, and mitigates risk.
• Formulates solutions to complex and ambiguous problems that are not well defined.
• Communicates complex technical ideas through daily work, presentations, and workshops.
• Collaborates with teams and management to make critical technical decisions that align with organizational goals.
• Champions six sigma techniques and drives standardization through continuous process improvement.
• Identifies and manages Six Sigma projects internal and external to the quality department as well as suppliers.
• Supports, leads, or manages front room and/or back room for internal and external QMS audits and/or investigations.
• Provides leadership, coaching, and/or mentoring to level I, II and level III engineers.

Requirements

• Bachelor's degree in engineering or related field and 6+ years of relevant experience, or equivalent combination of both.
• Certified Quality Engineer (CQE) preferred.
• Six Sigma Blackbelt and Certified Reliability Engineer (CRE) certifications preferred.
• Experience in the medical device industry and understanding of medical device quality systems and applications is desired.
• Ability to effectively influence and negotiate with all levels of an organization and lead effective/successful change initiatives.
• Ability to lead the design of complex, interconnected systems or processes that shape the organization's technical direction.

Supervisory Responsibilities

• Provides leadership, coaching, and/or mentoring to level I, II and level III engineers.
• May have direct reports of technicians or level I & level II engineers.