Description

Position Summary:

The Product Quality Engineer will support multiple products across various stages of lifecycle development. Responsibilities include implementation of design and manufacturing changes, authoring design control documents, developing risk management file documentation, executing verification and validation testing, ensuring product meets quality requirements, and managing quality system requirements. This position will report to the Director of Quality & Regulatory and will work closely with external vendors, consultants, and customers as well as the 410 Medical team.

Duties and Responsibilities:

•  Serve as a core team member of 410 Medical’s internal quality team with focus on new product development and existing product management 
• Interface with clinicians in hospital, EMS, and military settings to understand the user needs of existing and future products 
• Author and/or review product development deliverables such as design input/output matrix, design specifications, isolation diagrams, and verification and validation test plans/reports 
• Author and/or review risk management deliverables such as design FMEA, use FMEA, process FMEA, hazard analysis, etc. 
• Develop and validate test methods
• Develop and execute test plans for verification and validation of new and existing products 
• Assist and/or own contract manufacturer documentation oversight including nonconformances, rework, and corrective/preventive actions. 
• Collaborate with team members to identify design and manufacturing changes, and lead the documentation and implementation across the contract manufacturer and 410 Medical quality systems 
• Assist quality management in maintaining quality system requirements including document control, complaint management, CAPA management, and training as required 
• Assist quality management in audit readiness and audit execution 
• Perform root cause analyses; propose and implement effective solutions 
• Support 510(k) submissions as necessary     

Requirements

Skills/ Qualifications: 

• BS or MS in Engineering and 3-8 years of work experience 
• Experience in product lifecycle management and quality for medical products regulated by the FDA 
• Experience with Design Controls including design inputs, design changes, design verification and validation, and design transfer 
• Experience with ISO 14971 risk management processes, including authoring risk management file documentation 
• Experience with change management and implementation
• Ability to work with multiple outside vendors for quality, design, and manufacturing support
• Ability to meet goals across multiple projects and priorities
• Strong communication skills, ability to convey ideas in a clear, concise manner
• Focus on collaboration: between co-workers, customers and hospital staff
• Strong customer-service work ethic
• Ability to shift focus in a rapidly changing environment

Desired Experience: 

• IEC 60601-1 medical electrical equipment, IEC 62304 medical device software 

Other Requirements and Details:

• Full-time role based in Durham, NC
• Limited travel involved; less than 10% travel to contract designers / manufacturers as required 
• Must be able to meet credentialing requirements in order to observe product use within a hospital, EMS, or military environment