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 Product Development Engineer will be a key team member of 410 Medical’s R&D team and will focus on developing new life-saving devices for hospital, EMS, and military settings as well as providing ongoing engineering support for the existing LifeFlow product line. This role will require strong technical and project management skills and keen attention to detail. The ideal candidate has experience with medical device product development, mechanical design, working in quality management systems, and technical writing. The specific roles and responsibilities include those listed below.

Duties and Responsibilities:

 Serve as a core team member of 410 Medical’s internal R&D team with focus on new product development and existing product support.

 Interface with clinicians in hospital, EMS, and military settings to understand the user needs of existing and future products.

 Design subsystems of new product development projects and collaborate with external engineering partners.

 Develop early concepts for addressing complex unmet user needs in the clinical environment. Prototype, test, and iterate early concepts and assess engineering, regulatory and marketplace feasibility of each.

 Develop new test methods and analysis techniques based on user and product requirements

 Troubleshoot prototypes and quickly develop practical design improvements.

 Create CAD models, component specifications, part drawings, Bills of Materials (BOMs).

 Generate and maintain key documentation including test protocols and reports, risk assessments, FMEAs, product requirements, assembly instructions, and other quality system documents.

 Support ongoing manufacturing of the LifeFlow product lines by interfacing with manufacturing partners to maintain a consistent supply of high-quality products to 410 Medical’s customers.

 Aid in the resolution of customer complaints and root cause analyses on products in the field.

 Develop and validate test methods to evaluate new and existing products.

 Support Sales & Marketing by providing technical product guidance.

 Other duties as assigned  

Skills/ Qualifications:

 BS or MS in Mechanical or Biomedical Engineering and 3-8 years related WORKING experience

 Experience with mechanical design (preferably of medical devices), prototyping, and design for manufacturing

 Desired skills: experience designing electromechanical systems as part of a cross- functional team, statistical analysis

 Proficiency with SolidWorks or other similar CAD programs

 Demonstrated leadership and project management skills

 Strong communication skills, ability to convey ideas in a clear, concise manner

 Demonstrated technical writing skills

 Experience with design controls and product risk management

 Focus on collaboration: between co-workers, customers and external partners

 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; approximately 5% travel to hospitals or conferences

 Must be able to meet hospital credentialing requirements in order to observe products within a hospital or EMS 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