Medical Device Product Development Manager Jobs in Raleigh, NC

VQ Biomedical, based in the Research Triangle Park area of North Carolina, is an early-stage medical device company developing an innovative central venous catheter that 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) capable of delivering supplemental oxygen independent of the injured lungs, allowing them to rest, heal, and recover.

The Director of R&D plays a vital role in the leadership of the company. This person will craft and execute R&D strategy, build and lead the R&D team, and drive complex device development from concept through benchtop and preclinical testing and into early clinical evaluation, while ensuring FDA and ISO compliance throughout. This is a hands-on, early-phase role that pairs bench-level engineering with technical leadership. This is a full-time, in-person position that reports to the CEO.

• Develop and execute the R&D strategy and technical roadmap in support of the company’s development and regulatory milestones
• Build, mentor, and directly manage the R&D team as the company scales
• Lead the hands-on design, prototyping, and iteration of the oxygenation catheter and its components
• Develop and execute benchtop testing to characterize and verify device performance
• Own technical requirements, design inputs and outputs, and verification and validation planning as the design matures
• Lead risk management activities, including risk analyses and mitigation, in accordance with ISO 14971
• Establish and maintain the Design History File and supporting quality documentation for new designs and revisions to existing designs
• Plan, execute, and support preclinical (in vivo) studies in partnership with contract research organizations and clinical experts, and translate findings into design improvements
• Work cross-functionally with contract manufacturers to build prototypes, develop processes, and establish pilot manufacturing for new products
• Partner with QA/RA to ensure all R&D activities adhere to ISO 13485, FDA 21 CFR Part 820, and GMP standards
• Develop schedule and budget estimates, and take responsibility for achieving technical milestones on schedule and on budget
• Support technical reporting and deliverables for federal grants and contracts
• Other duties as directed

• Bachelor’s or Master’s degree in engineering (biomedical, mechanical, or related field)
• Minimum of 10 years of relevant medical device product development experience, preferably in a fast-paced small business or startup environment
• Proven experience in medical device design, specifically catheter design and construction
• Experience developing and documenting designs within an established, FDA-compliant quality system, including design controls, ISO 13485, and ISO 14971
• Experience developing benchtop test methods and characterizing device performance
• Experience planning and supporting preclinical or animal studies
• Experience starting new manufacturing lines for new products
• Familiarity with government contract and grant reporting
• Proficiency with CAD
• Ability to work in a fast-paced environment and work additional hours as required
• Ability to adapt to a changing environment and identify and solve problems efficiently
• Prior experience in a startup environment is a plus
• 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.