Job 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 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.
Requirements:
- 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. - 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.