R+D Quality Engineer III

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.

• Plans, leads, and manages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO
  9001:2015, ISO
  13485:2016, ISO
  14971, 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.

• 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.

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.

• 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.

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

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