R+D Quality Engineer III

Midmark Corporation; Kentucky; Sur place; USD 95 000 - 135 000; Plein temps

Résumé du poste

Midmark Corporation in Versailles, OH, is seeking an R&D Quality Engineer III to lead quality initiatives for new product development in the medical device field. You will plan, monitor, and drive risk management and design validation activities, ensuring robust design and manufacturability.

The role requires a technical engineering background, 4+ years of relevant experience, and preferred CQE/ Six Sigma CRE certifications.

Qualifications

• Bachelor's degree in engineering or related field and 4+ years of relevant experience.
• CQE / Six Sigma Black Belt / CRE certifications preferred.
• Experience in the medical device industry is desired.
• Strong written and verbal communication skills.
• Ability to apply advanced analytical tools to complex problems.

Responsabilités

• Plans, leads, and manages quality deliverables on NPD projects.
• Leads risk management processes and creates RM documentation.
• Reviews and approves PRP documentation including test specs and design records.
• Facilitates the design and process FMEA process.
• Leads site-based quality initiatives as SME.
• Mentors engineers I & II in technical and collaboration skills.
• Applies Six Sigma and drives continuous improvement.

Connaissances

Medical device industry

Communication skills

Analytical tools

System design leadership

Formation

Bachelor's degree in engineering or related field

Outils

Microsoft Word

PowerPoint

Excel

Project

Minitab

Description du poste

The R + D Quality Engineer III leads and enforces product development quality initiatives through identifying, investigating, planning, and conducting activities aimed at insuring robust and quality design and manufacturability of medical devices.

ESSENTIAL/PRIMARY DUTIES:

• Plans, leads, and manages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO9001:2015, ISO13485:2016, ISO14971, FDA, CSA, and EU MDR regulations.
• Leads all risk management processes and creates risk management documentation for (NPD) projects.
• Creates, reviews, and approves documentation related to the engineering Product Realization Process (PRP). Documentation includes, but is not limited to, change requests, engineering orders, product and component test specifications and design records.
• Facilitates the design and process failure mode and effects analysis (FMEA) process.
• Leads site-based quality department initiatives as a subject matter expert (SME).
• Applies domain expertise to the application and advancement of engineering methods and tools. Leads the application of six sigma techniques and drives continuous process improvement.
• Collaborates with cross-functional teams to align decisions with business goals.
• Mentors engineer I & II teammates, focusing on technical skills, collaboration skills, and cultural competencies.
• Applies advanced tools and methods to solve complex problems. Tackles technical challenges and contributes to troubleshooting effort.

SECONDARY DUTIES:

• Supports internal and external quality system audits.
• Leads the creation of threat models and cybersecurity risk assessments.
• Leads the creation and maintenance of the products Usability Engineering Files, provides misuse cases involving use error and assesses the impact.
• Assists with the creation of the reliability predictions for projects with recommended testing profiles and analyzes test results.

EDUCATION and/or EXPERIENCE:

Bachelor's degree in engineering or related field and 4+ years of relevant experience, or equivalent combination of both. Certified Quality Engineer (CQE), Six Sigma Blackbelt (DMAIC, DMADV), and Certified Reliability Engineer (CRE) certifications preferred.

COMPETENCY and/or SKILL:

• Experience in the medical device industry and understanding of medical device quality systems and applications is desired.
• Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
• Strong written and verbal communication skills
• Ability to apply advanced analytical tools and methods to solve complex problems
• Ability to lead the design of complex systems and identify new technological opportunities

SUPERVISORY RESPONSIBILITIES:

• Provides leadership, coaching, and/or mentoring to level I and level II engineers.

About Us

Founded in 1915, Midmark Corporationisthe only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments.With more than 2,200teammates worldwide, Midmark focuses on harmonizing space, technology and workflows, creating a better experience for caregivers and patients at the point of care.The Midmark headquarters and innovation hub are located in Versailles, Ohio, which is also home tothe Midmark Experience Center, Design Center, Technology Center and our largest manufacturing facility. Midmark maintains eleven additional locations in the United States, including four innovation hubs, and has subsidiaries in India and Italy.

EO/AA Employer Minorities/Females/Protected Veterans/Disabled

Job Info

• Job Identification 4597
• Job Category Engineering
• Posting Date 07/13/2026, 01:03 PM
• Job Schedule Full time
• Job Shift Day
• Locations 60 Vista Dr, Versailles, OH, 45380, US 9987 Carver Road, Blue Ash, OH, 45242, US