Associate Manager, R&D

VB Spine, LLC•Allendale, NJ

4d•$125,000 - $135,000•Onsite

About The Position

VB Spine is seeking an Associate Manager, R&D to step into a people-leadership role. In this position, you will develop engineers, drive sustaining excellence, and help ensure the continued success of innovative spinal products that improve patient lives. You will coach, develop, and manage direct reports, manage resource planning and allocation, and interface with surgeons and sales representatives to gather clinical input. You will utilize advanced knowledge of surgical procedures to drive innovative solutions, lead or participate on cross-functional design teams, and collaborate closely with various departments to ensure project success. Additionally, you will participate in and lead design reviews, develop and manage metrics for senior leadership, approve verification and validation activities, and support regulatory submissions. You will also lead the creation and refinement of engineering documentation, mentor others on industry standards, identify and implement improvements, develop and manage budgets, write annual performance reviews, and establish strong working relationships across the organization and with external partners.

Requirements

Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or related discipline (Master’s preferred or equivalent relevant experience)
6+ years of relevant work experience (medical device industry preferred)
Demonstrated success in product development, bringing concepts to market, and/or managing R&D sustaining activities, product transfers, NC/CAPA, or remediation
Experience managing multiple technology projects from inception to launch
Strong knowledge of orthopedic products (Spine preferred), including clinical issues and performance requirements
Experience working within international regulatory requirements (FDA, EU, ROW) in the medical device industry
Excellent verbal and written communication skills, including strong technical writing ability
Ability to interface effectively with physicians, engineers, and operational personnel
Demonstrated ability to manage multiple priorities and work with remote teams

Nice To Haves

Previous supervisory experience is a plus
Applied knowledge of parametric CAD packages (Creo or SolidWorks preferred) is a plus

Responsibilities

Coach, develop, and manage direct reports to meet performance objectives and support their professional growth
Manage resource planning and allocation of personnel and equipment for the product development and sustaining portfolio
Interface with surgeons and sales representatives to gather clinical input for product design and evaluation
Utilize advanced knowledge of surgical procedures to drive innovative solutions that meet customer needs
Lead or actively participate on cross-functional design teams and manage large sustaining projects
Collaborate closely with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to ensure project success
Participate in and lead design reviews and product investigations
Develop and manage metrics and reporting for senior leadership
Approve verification and validation activities for product designs
Support regulatory submissions including 510(k), PMA, and CE Mark
Lead creation and refinement of engineering documentation such as Design History Files and Change Control records
Mentor others on industry standards, design requirements, test strategies, design controls, risk management, and NC/CAPA processes
Identify and implement improvements to reduce cost, increase efficiency, and strengthen organizational capabilities
Develop and manage expense budgets and team spending
Write annual performance reviews for direct reports
Establish and maintain strong working relationships across Spine R&D, other VB sites, and external partners