Project Engineer
VB Spine · Allendale, NJ · 1 mo ago
$100k–$110k/yrFull-time
About the role
Join our mission-focused team at VB Spine, a leading privately held spine company and one of the largest family-owned medical technology companies globally. As a Project Engineer in our R&D function, you'll play a crucial role in advancing sustaining projects for commercially available spinal products.
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
Requirements
- Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or related discipline (Master’s preferred)
- 2+ years of relevant work experience
- 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
Qualifications
- Advanced understanding of customer needs, product intended use, and clinical procedures
- Strong problem-solving skills
- Excellent communication and collaboration abilities