Sr. Development Quality Engineer

4 weeks ago


Pleasanton, United States Spectraforce Technologies Full time

Position Title: Sr. Development Quality EngineerLocation: Pleasanton CA 94588Assignment Duration: 6 monthsSchedule: 8 AM to 5 PMWork Arrangement: OnsitePosition SummaryThe Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.Key ResponsibilitiesLead and/or support on-time completion of Design Control deliverablesSupport the establishment of objective, measurable, and verifiable product requirementsSupport Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activitiesLead Risk Management activities from product concept through commercializationSupport test method development and lead test method validation activitiesSupport manufacturing process development & qualification for new product and design changesSupport the establishment of component specification definitions, supplied component sampling plan development, and vendor qualificationsSupport biocompatibility and sterilization qualificationsSupport audits and quality system improvement activitiesSupport Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.Comply with 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 & ExperienceBachelor'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 validationExperience in preparing risk assessments, FMEA and other risk documents.Advanced Degree in Engineering/Technical FieldExperience 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 #J-18808-Ljbffr



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