Senior Development Quality Engineer

Senior Development Quality Engineer Contract: Pleasanton, California, US Salary Range: 55.00 - 62.00 | Per Hour Job Code: 365177 End Date: 2025-11-23 Days Left: 26 days, 20 hours left Pay Range: $55 - $62/hour Position Details Industry: Medical Device Job Title: Senior Development Quality Engineer Location: Pleasanton, CA 94588 Duration: 6 months (Possible extensions / conversion into full time) Description: The 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. 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. Basic Qualifications: • 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 Qualifications: • 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? The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)