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Urgent! Engineer III,R+D Quality Job Opening In Cincinnati – Now Hiring Midmark Corporation

Engineer III,R+D Quality



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 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 ISO:, ISO:, ISO, 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 + 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.

  • Required Skill Profession

    Engineers



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