Senior Research & Development Engineer
Company Summary:
VQ Biomedical, based in the Research Triangle Park area of North Carolina, is an early-stage medical device company focused on developing an innovative central venous catheter which delivers oxygen directly to the bloodstream in critically ill ICU patients suffering from lung injury and respiratory failure.VQ is developing the first minimally-invasive alternative to mechanical ventilation and ECMO (extracorporeal membrane oxygenation) that is capable of delivering supplemental oxygen independent of the injured lungs allowing them to heal, rest, and recover.
Position Summary:
The Senior Research and Development Engineer will be a critical team member that designs, develops, verifies and validates new products from concept through regulatory clearance and production. Reporting to the VP of R&D, this position will collaborate closely with vendors, clinicians and customers, in addition to the VQ Biomedical team.The ideal candidate will be a self-starter with a strong work ethic, integrity, and the ability to work independently as well as part of a team. They must be proactive and thrive in a fast-paced entrepreneurial environment. The preferred candidate will have previous experience designing complex intravenous catheters.
This is an exciting opportunity to join an accomplished team during an early phase of 1^st generation product design.
The specific roles and responsibilities include those listed below.
Duties and Responsibilities:
- Act as the technical contributor on a new product development team, developing a central line venous catheter
- Concept development, prototyping, product design, verification & validation testing including authoring and executing protocols and reports, and providing support through production scale up
- Create and maintain design control related documentation such as risk and usability assessments, user needs, and design inputs. Comply with requirements of design controls and other regulatory bodies
- Design products in conjunction with the external supplier group requirements in order to deliver a design that is manufacturable
- Meet with potential customers to observe use and build understanding of user needs
- Support Marketing & Sales with competitive product analysis and performance testing
- Other tasks as required
Skills/ Qualifications:
- BS/MS in engineering (Mechanical or BME preferred)
- 8 to 12 years medical device design experience
- Prior experience designing complex catheters preferred
- Familiarity with SolidWorks, CAD, Mechanical Design, and Statistical Analysis
- Strong communication skills, ability to convey ideas in a clear, concise manner
- Previous experience working within a quality management system for the FDA
- Focus on collaboration: between co-workers, customers and hospital staff
- Strong customer-service work ethic with a “patient first” mentality
- Ability to shift focus in a rapidly changing environment
- Good prototyping skills - formulation of creative ideas to demonstrate idea feasibility and ability to assemble and test prototypes
Other Requirements and Details:
- Full-time, exempt role based in Raleigh-Durham North Carolina
- Limited travel involved; less than 5% travel to hospitals or conferences
- Must be able to meet hospital credentialing requirements in order to observe products within a hospital environment
VQ Biomedical is interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.
VQ Biomedical 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.