R+D Quality Engineer III

Midmark Corporation; Versailles (OH); On-site; USD 80,000 - 100,000; Full time

Job summary

Midmark Corporation, located in Versailles, Ohio, is seeking an R + D Quality Engineer III to lead and enforce product development quality initiatives. The successful candidate will be responsible for managing quality deliverables on new product development projects according to regulatory standards.

Expanding on risk management processes, documentation, and mentoring of junior engineers are key aspects of this vital role. Candidates should have a Bachelor's degree in engineering, relevant experience, and strong analytical skills.

Qualifications

• 4+ years of relevant experience or an equivalent combination of education and experience.
• Experience in applying engineering methods and tools, with Six Sigma techniques.
• Solid understanding of medical device quality systems.

Responsibilities

• Leads quality deliverables on new product development projects.
• Manages risk management processes and documentation.
• Mentors engineer I & II teammates in technical and collaboration skills.
• Facilitates design and process failure mode effects analysis.

Skills

Experience in the medical device industry

Strong written and verbal communication skills

Ability to apply advanced analytical tools

Leadership and mentoring skills

Mastery of software programs

Education

Bachelor's degree in engineering or related field

Certified Quality Engineer (CQE)

Six Sigma Blackbelt (DMAIC, DMADV)

Certified Reliability Engineer (CRE)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Minitab

Microsoft Project

Job description

Job Summary

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

Essential 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 Experience

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

Competency and Skills

• Experience in the medical device industry and a solid understanding of medical device quality systems and applications.
• 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.

EEO Statement

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