Senior Mechanical Design Engineer (Product Quality)

Regulatory Jobs; Ohio; On-site; USD 90,000 - 130,000; Full time

Job summary

Regulatory Jobs seeks a seasoned quality leader to oversee regulatory compliance across medical devices. You will drive the QMS and collaborate with R+D, manufacturing, service, and supply chain to ensure quality, compliance and cost targets.

Leading Six Sigma initiatives, you will mentor engineers and guide audits, while aligning decisions with company goals. Prior CQE/CRE certifications and 6+ years in medical device quality are preferred.

Qualifications

• Bachelor’s degree in engineering or related field required; 6+ years of relevant experience.
• CQE, Six Sigma Black Belt and CRE certifications preferred.
• Experience in the medical device quality systems and regulatory requirements.

Responsibilities

• Lead cross-functional teams to ensure regulatory compliance of medical devices.
• Develop and improve the Quality Management System (QMS).
• Drive Six Sigma projects and continual process improvement.
• Mentor engineers and support internal/external audits.

Skills

Regulatory knowledge

Influencing others

Quality systems

Problem solving

Technical leadership

Education

Bachelor's degree in engineering or related field

Certified Quality Engineer (CQE)

Six Sigma Black Belt

Certified Reliability Engineer (CRE)

Job description

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.