Project Engineer

VB Spine, LLC•Allendale, NJ

9d•$90,000 - $110,000

About The Position

VB Spine is seeking a Project Engineer to join their high-performing R&D team. This role will contribute to the sustainment and evolution of innovative spinal implants and instruments that improve patient lives. The Project Engineer will interface with surgeons, utilize knowledge of surgical procedures to develop innovative solutions, and design, develop, modify, evaluate, and verify mechanical components for medical devices. Collaboration with various internal teams and adherence to quality management system procedures are key aspects of this position.

Requirements

Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or related discipline
2+ years of relevant work experience
Working knowledge of mechanical engineering practices and design principles
Moderate technical ability to create engineering drawings and models, applying GD&T and CAE tools
Moderate experience with a parametric CAD package (Creo or SolidWorks preferred)
Demonstrated ability to apply knowledge of materials and manufacturing processes to product design
Familiarity with design controls within a regulated industry
Basic project management skills with the ability to lead small projects
Good technical communication skills
Ability to work with a medium level of supervision while providing basic strategic and moderate tactical input

Nice To Haves

Master’s degree preferred

Responsibilities

Interface with surgeons to gather input for design and evaluation of new and existing products
Utilize knowledge of surgical procedures to develop innovative solutions that meet customer needs
Design, develop, modify, evaluate, and verify mechanical components for medical devices under minimal supervision
Collaborate with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management teams to ensure project success
Participate in and lead design reviews and change control initiatives as applicable
Independently create and refine engineering documentation, including Design History Files, Change Control, Nonconformance & CAPA records, and Regulatory Technical files
Translate design inputs into engineering specifications and produce sub-system level designs
Develop and analyze solutions, including prototyping options to provide proof of concept
Follow design controls, risk management, change control, and NC/CAPA procedures per the Quality Management System
Demonstrate advanced understanding of customer needs, product intended use, and clinical procedures
Apply fundamental and some advanced concepts for problem solving
Actively contribute to the technical and cultural growth of the organization
Work as a key team member while demonstrating ownership and prioritizing work with minimal supervision