Quality Engineer 2

Intuitive • Sunnyvale, CA

1d

About The Position

Primary Function of Position The Quality Engineer II supports product development from concept through commercialization and will serve as the core team member with the cross-functional product development team. The Quality engineer will provide support for design control and risk management, Design for Reliability and Manufacturing, product Development Life Cycle, and Process Validation. In addition, this position will play an active role to ensure that the developed products meet quality standards consistent with Intuitive’ s quality processes, while meeting design control and regulatory requirements.

Requirements

• Minimum Education: Bachelor’s in engineering or STEM
• Advanced degree preferred with 2+ years of working experience in Quality Engineering or related field, minimum 2 years in medical device environment.
• Experience and familiarity with respect to design control and risk management from early design and development through commercialization.
• Demonstrated experience with electromechanical devices.
• Experience with medical standards: ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization.
• Able to navigate quality system with minimal oversight on individual projects.
• Balanced risk decision making to drive product quality, gain consensus, and work through technical challenges.
• Able to articulate complex information to teams, including managment
• Minimum BS in Engineering or STEM discipline is required.
• Minimum 3 years of experience in a regulated industry with 1 years in Medical Device

Nice To Haves

• Experience with data analysis tool. i.e., Tableau, PowerBI, etc.

Responsibilities

• Work closely with product development teams.
• Monitor priorities and tracks progress against schedules; and communicates status to management.
• Provide support in the implementation and policing of GMP, ISO and FDA requirements.
• Experience and excellent understanding of pFMEAs, Root Cause, CAPAs, Non-Conformance, and Process Validation
• Experience with product investigation, Identifying root cause and implementing appropriate solutions
• Familiarity with data analysis tools and statistical methods (i.e., ANOVA, DOE, etc.)
• Provide statistical support and analytical problem solving for manufacturing, technical services, and product development to identify root cause of problems
• Experience with computerized systems, such as SAP, Trackwise, Agile, etc.
• Experience in product design changes, manufacturing changes, supplier changes and the associated requirements to execute such changes.
• Support Regulatory Affairs with creating submissions and responding to submission questions.
• Support internal and external audits, including preparation and direct interaction with auditors.
• Support manufacturing and work cross-functionally to resolve technical problems
• Support, designs and implements methods and/or procedures for inspecting, testing, and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.
• Author technical documents with sufficient clarity, detail and correctness
• Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is an asset.
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level