Senior Design Project Engineer, Quality (35556)

Senior Design Project Engineer, Quality
Greenville, OH

Pay: $118K-140K
Benefits: Comprehensive Client Benefit Package

SUMMARY:
Leads the efforts to identify, investigate, plan, and conduct activities to enhance quality through design and manufacturing of medical devices and components. Work cross-functionally with R+D engineering, manufacturing, technical service, and supply chain to lead quality, compliance and cost of medical devices and components.
 
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.
• Ensures that products and product changes comply with all specified regulatory agencies (FDA, ISO, UL, CSA, etc.).
• Collaborates with leadership and other cross functional departments to align decisions 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.
• Provides leadership, coaching, and/or mentoring to the co-op group and level I, II & III engineers.
• 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.
• May have direct reports of technicians or level I & level II 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.

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