Generis Tek Inc · 1 day ago
Engineer - Degreed V_SJM
Pleasanton, CA
Full-time
Onsite
Senior Level
$60/hr - $60/hr
5+ years expGeneris Tek Inc is a boutique IT and professional staffing company based in Chicago land. They are seeking a Senior Development Quality Engineer to provide design quality expertise to a product development team, ensuring patient safety and customer satisfaction through collaborative efforts with cross-functional teams.
Information Technology & Services
Responsibilities
Lead and/or support on-time completion of Design Control deliverables
Support the establishment of objective, measurable, and verifiable product requirements
Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
Lead Risk Management activities from product concept through commercialization
Support test method development and lead test method validation activities
Support manufacturing process development & qualification for new product and design changes
Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
Support biocompatibility and sterilization qualifications
Support audits and quality system improvement activities
Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements
Comply with Abbott, U.S. FDA, EUMDR and other requirements, as applicable
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers
Qualification
Required
Bachelor's degree in Engineering or Technical Field
Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development
Experience in medical devices and associated regulations/standards
Experience in test method development and validation
Experience in preparing risk assessments, FMEA and other risk documents
Preferred
Advanced Degree in Engineering/Technical Field
Experience in active implantable medical devices
Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA)
Working knowledge of statistics and its application to verification and validation?
Company
Generis Tek Inc
Generís Tek is an elite IT staffing firm headquartered in Chicago, IL offering long-term, short-term, temporary-to-permanent and direct placement staffing.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase