Project EngineerLocation: Leesburg, VA or Allendale, NJ (Hybrid - 3 days onsite | Up to 20% Travel)
Company: VB Spine
As a
Project Engineer in our R&D function within the Spine division, you'll perform implant and instrument design work, lead small projects, and actively participate on multi-functional teams to advance sustaining projects for commercially available products - including product evolution, regulatory documentation updates, and supply chain continuity.
What You'll Do:- 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
What You Bring:- Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or related discipline (Master's preferred)
- 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
Compensation:Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $90,000.00 - $110,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, technical expertise, and market conditions.
