Staff EngineerLocation: Leesburg, VA or Allendale, NJ
Company: VB Spine
As a
Staff Engineer in our R&D function within the Spine division, you'll perform complex implant and instrument design work, lead large 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 and sales representatives to gather input for design and evaluation of product enhancements and sustaining projects
- Utilize advanced knowledge of surgical procedures to develop innovative solutions that meet customer needs
- Independently design, develop, modify, evaluate, and verify mechanical components and subsystems for medical devices
- Lead large projects and actively participate on cross-functional design teams (R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management)
- Participate in and lead design reviews as applicable
- Lead creation and refinement of engineering documentation, including Design History Files, Change Control, Nonconformance & CAPA records, and Regulatory Technical documentation
- Translate user needs into design inputs and specifications and produce complex system-level designs
- Conduct advanced prototyping and testing; develop fixtures for verification testing as needed
- Analyze and correct complex product design issues using independent judgment
- Support Voice of Customer sessions internally and with clinicians
- Prepare and review information for invention disclosures and patent applications
- Mentor others on industry standards, design requirements, test strategies, design controls, risk management, and change control per the Quality Management System
- Identify and support improvements to procedures, policies, processes, systems, and technology
- Apply knowledge of materials, manufacturing processes, and Design for Manufacturability (DFM) principles
- Deliver high-quality results while collaborating across teams to achieve business objectives
What You Bring:- Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or related discipline (Master's preferred)
- 4+ years of relevant work experience
- Strong technical ability to develop and optimize designs for mechanical assemblies incorporating DFM principles
- High proficiency with parametric CAD packages (Creo or SolidWorks preferred) and strong skills in creating engineering drawings, models, GD&T, and CAE tools
- Adept at applying knowledge of materials and manufacturing processes to product design
- High level of experience and demonstrated proficiency with design controls within a regulated industry
- Moderate project management skills, including building timelines and budgets and monitoring progress
- Ability to communicate moderate-complexity plans and technical information clearly
- Ability to work with a low level of supervision while providing moderate strategic and tactical input
- Responsible for leading large projects
Compensation:Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $115,000.00 - $125,000.00 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.
Benefits include:- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO) and holidays
- Ongoing training and professional development opportunities
- Opportunity to grow within a fast-paced, dynamic company
