Senior Mechanical Design Engineer (Product Quality)

Regulatory Jobs; Versailles (OH); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Regulatory Jobs seeks a Quality Engineer to lead efforts in identifying, planning, and conducting activities that improve or ensure quality in medical device design and manufacturing. You will collaborate with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance, and cost, serving as the SME in the quality department.

The role emphasizes cross-functional leadership, QMS development, and Six Sigma-driven process improvements supporting regulatory

Qualifications

• Bachelor's degree in engineering or related field (required).
• CQE, Six Sigma Black Belt and CRE certifications preferred.
• Experience in the medical device industry and understanding of medical device quality systems.
• Ability to influence and negotiate with all levels of an organization and lead change initiatives.
• Ability to establish and enforce quality standards aligned with regulatory requirements.

Responsabilités

• Ensures products and changes comply with regulatory agencies (FDA, ISO, UL, CSA).
• Creates and improves the QMS to ensure compliance with regulatory requirements.
• Drives product quality improvements with design, manufacturing, and supply chain.
• Acts as a technical lead and manages significant systems with strategic planning and risk mitigation.
• Formulates solutions to complex, ill-defined problems using feedback and collaboration.
• Communicates complex technical ideas through daily work, presentations, and workshops.
• Fosters cross-team communication and collaborates with leadership to align decisions with goals.
• Champions Six Sigma and drives standardization through continuous process improvement.
• Identifies and manages Six Sigma projects across quality and supplier domains.
• Provides coaching to engineers and supports audits and investigations.

Connaissances

Quality engineering

Six Sigma

Regulatory compliance

Cross-functional leadership

Problem solving

Formation

Bachelor's degree in engineering or related field

Certified Quality Engineer (CQE)

Six Sigma Black Belt

Certified Reliability Engineer (CRE)

Description du poste

JOB SUMMARY:

Leads the efforts to identify, investigate, plan, and conduct activities to improve or ensure quality through design and manufacturing of medical devices and components. Leads cross-functionally with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance and cost of medical devices and components. Will act as the subject matter expert (SME) on elements within the quality department.

ESSENTIAL/PRIMARY DUTIES:

• Ensures that products and product changes comply with all specified regulatory agencies (FDA, ISO, UL, CSA, etc.).


• 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. Incorporates feedback and solutions from others.


• Communicates complex technical ideas through daily work, presentations, and workshops.


• Fosters cross team communication and knowledge sharing. Collaborates with teams and management to make critical technical decisions that align with organizational goals.


• 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.

SECONDARY DUTIES:

• 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.


• Teaches and provides guidance on engineering documentation such as engineering drawings, bill of materials, change orders, testing documents and DHF/DMR records.

EDUCATION and/or EXPERIENCE:

Bachelor's degree in engineering or related field and 6+ years of relevant experience, or equivalent combination of both. Certified Quality Engineer (CQE), Six Sigma Blackbelt and Certified Reliability Engineer (CRE) certifications are preferred.

COMPETENCY and/or SKILL:

• 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 establish and enforce quality standards that align with industry best practices and regulatory requirements


• Expert problem solver in areas of expertise


• Ability to lead the design of complex, interconnected systems or processes and 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.