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Design Quality Engineer - San Jose, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:
Working knowledge of CFR 21 820, ISO 13485, ISO 14971, IEC 10993, IEC 60601 standards and ROHAS/REACH compliance
Implementation GD&T and tolerance analysis in mechanical design outputs
ASQ QE, Lead Auditor certifications preferred
Must be detail oriented, well organized and have excellent communication skills
Ability to manage multiple projects at the same time
Ability to write reports, customer facing correspondence, and procedure manuals
Understanding of electromechanical and software devices
Experience in working with internal MFG or external CM partners on NPI MFG process, testing protocol and fixture.
Familiarity with medical imaging systems hardware, especially ultrasound preferred
Familiarity with software and electrical development and collaboration tools (e.g., Jira, JAMA, GitHub) preferred
Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures.
Requirements:
Support Electrical Safety and EMC standards and testing (IEC , IEC and determining root-cause and resolving issues in complex electro-mechanical systems
Support Program Management with compliance to Design Controls and Risk Management procedures and delivery of robust Design History Files
Develop and implement product quality plans and risk management plans to ensure a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes.
Demonstrate leadership and expertise in mechanical development especially for hazard analysis/failure mode effects analysis (FMEA) and participate in the formal release process for medical devices satisfying quality and regulatory requirements.
Minimum of 10 years of related experience with a bachelor's degree; or 8 years and a master's degree; or a PhD with 3 years' experience; or equivalent experience in medical devices industry.