Senior Design Project Engineer, Quality (35556)

STSI (Staffing Technical Services Inc.); Kentucky; On-site; USD 118,000 - 140,000; Full time

Benefits offered by this job

Comprehensive Benefits Package

Job summary

STSI (Staffing Technical Services Inc.) is seeking a Senior Design Project Engineer, Quality in Greenville, OH. The role leads quality activities across design and manufacturing of medical devices and components, interfacing with R&D, manufacturing, technical service, and supply chain.

The position requires a Bachelor's in engineering, 6+ years of experience, CQE is preferred, and Six Sigma Black Belt and CRE certifications are desirable. A comprehensive client benefits package is provided.

Qualifications

• Bachelor's degree in engineering required or equivalent.
• CQE and Six Sigma Black Belt certifications preferred.
• CRE certification preferred.

Responsibilities

• Lead the development and maintenance of the Quality Management System (QMS) to ensure regulatory compliance.
• Drive quality improvements across design, manufacturing, and supply chain.
• Act as technical lead for complex systems and risk mitigation.
• Communicate complex technical ideas and influence cross-functional decisions.
• Ensure product and changes comply with FDA, ISO, UL, CSA, and other standards.
• Support and mentor engineers and co-ops.

Skills

Leadership

Communication

Education

Bachelor's degree in engineering

CQE

Six Sigma Black Belt

Certified Reliability Engineer

Six Sigma Certification

Job description

Job Description

Job Description

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.