Ecocareers ยท 2 months ago
Sr. Development Quality Engineer
Pleasanton, CA
Full-time
Onsite
Senior Level
5+ years expConfidential company is seeking a Sr. Development Quality Engineer who will serve as a technical representative providing design quality expertise to a product development team. The role involves maintaining collaborative partnerships and ensuring patient/user safety, customer satisfaction, and organizational success through various quality engineering responsibilities.
Staffing & Recruiting
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 Client, 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
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase