Job Description

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 ***, 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"