R+D Quality Engineer

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

Requirements

• 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.
• Assists with safety risk management processes and creation of risk management documentation for (NPD) projects.
• Creates, reviews, and approves documentation related to the engineering Product Realization Process (PRP).
• Facilitates the design and process failure mode and effects analysis (FMEA) process.
• Applies advanced engineering methods and tools to solve engineering problems.
• Collaborates with cross functional/development teams to address quality concerns, drive improvements, and take ownership of technical solutions and their outcomes.
• Mentors co-op and engineer I teammates, focusing on technical skills and cultural competencies.
• Supports internal and external quality system audits.
• Assists with the creation of threat models and cybersecurity risk assessments.
• Assists with 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.