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.