Sr. Development Quality Engineer
387 Technology Circle Northwest Atlanta, GA 30313 US
*Depending on experience
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.
• 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 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.
• Bachelor’s degree in Engineering or Technical Field. Electrical Engineering preferred
• Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality
• Experience in electro-mechanical medical devices and associated regulations/standards.
• Experience in electrical engineering and/or medical device electrical safety
• Experience in preparing risk assessments, FMEA and other risk documents.
• Advanced Degree in Electrical Engineering or Biomedical Engineering with concentration in electrical systems
• 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
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.