Company Summary:
410 Medical, based in Durham, NC, is focused on innovative technology to improve resuscitation of critically ill patients. 410’s lead products, LifeFlow and LifeFlow Plus, are designed to enable clinicians to deliver fluids, blood and blood products more effectively and efficiently to patients with shock and sepsis in urgent need of rapid fluid or blood resuscitation. LifeFlow and LifeFlow Plus were cleared by the FDA in 2016 and 2020, respectively, and are currently in commercial use across the United States.
Position Summary:
The Quality Engineer / Senior Quality Engineer will support multiple products and
processes 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 VP 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, existing product management, and quality system management.
Quality Management System:
- Lead subsystems of the QMS – ensure quality and regulatory requirements are achieved in multiple subsystems such as document control, engineering change management, complaint management, CAPA management, training, etc.
- 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 audit readiness and audit execution
- Perform root cause analyses; propose and implement effective solutions
Product Development:
- 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 execute test plans for verification and validation of new and
existing products - Support documentation and preparation for 510(k) submissions
Interface with clinicians in hospital, EMS, and military settings to understand the user needs of existing and future products
Skills/ Qualifications:
- BS or MS in Engineering and 5-8 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 management of a medical device quality system compliant to ISO 13485 and 21 CFR 820
- Experience with change management and implementation
- Desired Experience: IEC 60601-1 medical electrical equipment, IEC 62304
medical device software - 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
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
For More Information and to apply, visit www.410medical.com
410 Medical is an equal opportunity employer. As such, we provide employment opportunities without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, military service, or other characteristics protected by law.