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R&D Manager
1 month ago
R&D Manager/Program Manager
Our client is looking for a creative hands-on R&D Manager with cardiovascular medical device experience. As the RD Manager, this role will have the opportunity work alongside a dynamic fast-paced engineering team and manage the development, timeline, testing, and commercializing of a novel catheter-based thrombectomy technology. Pivotal accomplishments for this role will be leading the product development efforts through individual contribution, managing of employees and consultants to a successful product clearance. This position will have the opportunity to frequently meet with physicians and senior management to have the ability to understand and learn about the unmet clinical need that we are addressing and to have input in the company's plan.
What Success Looks Like
- Development of a novel technology that exceeds customer's expectations
- Managing the product and team through the product development lifecycle in a timely manner leading to a 510(k) clearance.
- Finalizing product requirements that addresses the user needs
- Rapid designing and creating of prototypes and feasibility models for proof-of-concept testing
- Creation of intellectual property that protects the novel technology
What You Bring
- A passion for understanding why and pushing the technology to the next level
- Being hands-on in analyzing and solving problems and providing technical guidance for the engineering team
- Driving documentation, verification testing, risk management, and design processes needed for medical device products
- Managing mechanical and electrical design risks and developing solutions to mitigate them
- Clearing technical and logistical roadblocks that occur during the product design process
- Collaborating cross-functionally to build important connections that enable the team's success within the Company
Required Qualifications:
- Bachelor's/Master's degree in Mechanical, Electrical, or Biomedical engineering with 8+ years of relevant technical experience in the medical device field
- Demonstrated experience (3+ years) leading and managing development teams from concept to regulatory clearance for a patient-critical medical device
- Proven history of developing and transferring electro-mechanical catheter-based medical devices
- Experience working with external vendors and consultants
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