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 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.