Senior Design Project Engineer, Quality (35556)

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

Benefits offered by this job

Comprehensive Client Benefit Package

Job summary

STSI in Greenville, OH is seeking a Senior Design Project Engineer, Quality to lead quality initiatives in the design and manufacturing of medical devices and components.

The role requires a Bachelor's degree in engineering and 6+ years of relevant experience; CQE and Six Sigma Black Belt/CRE are preferred. You will drive QMS activities, audits, and cross-functional collaboration to ensure regulatory compliance.

Qualifications

• Bachelor's degree in engineering or related field.
• 6+ years of relevant experience or equivalent combination.
• CQE preferred.
• Six Sigma Black Belt and CRE certifications preferred.
• Experience in the medical device industry and understanding of quality systems is desired.
• Ability to influence and negotiate with all levels and lead change initiatives.
• Ability to design complex, interconnected systems or processes.

Responsibilities

• Maintain and improve the Quality Management System (QMS) for regulatory compliance.
• Drive product quality improvements with design, manufacturing, and supply chain.
• Provide technical leadership and risk mitigation for critical systems.
• Formulate solutions to complex, ill-defined problems.
• Communicate technical ideas through presentations and workshops.
• Collaborate across teams to align decisions with goals.
• Ensure compliance with FDA, ISO, UL, CSA and other agencies.
• Lead Six Sigma initiatives and standardization efforts.
• Identify and manage Six Sigma projects with internal and supplier teams.
• Mentor and coach engineers at multiple levels.
• Support or lead internal and external QMS audits and investigations.

Education

Bachelor's degree in engineering or related field

6+ years of relevant experience

CQE

Six Sigma Black Belt

Certified Reliability Engineer (CRE)

Influence and negotiation

Lead complex systems design

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.