Sr. Development Engineer - PRO

VB Spine, LLC•Leesburg, VA
•$105,000 - $135,000

About The Position

VB Spine is seeking a talented Development Engineer to join their high-performing R&D team. This role focuses on developing patient-specific and special instrument solutions to enable personalized spinal care and improve patient outcomes. The engineer will be responsible for the design, development, and verification of components and subsystems for medical devices, collaborating with various departments to ensure successful product development and launch. The position offers competitive compensation, benefits, and opportunities for growth within the company.

Requirements

  • Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or related engineering discipline
  • 2+ years of experience required
  • Proficiency with CAD software (SolidWorks or Creo preferred)
  • Working knowledge of FDA medical device design controls, risk management, and product development processes (ISO 14971, IEC 60601, ISO 13485)
  • Experience developing and documenting design requirements, verification plans, protocols, and reports
  • Experience designing components and assemblies for manufacturability using traditional manufacturing processes
  • Experience supporting prototype builds, bench testing, and design verification activities
  • Experience working in cross-functional product development teams
  • Ability to read, interpret, and create complex engineering drawings and specifications
  • Strong written and verbal communication skills with the ability to manage multiple assignments in a fast-paced environment

Nice To Haves

  • Master’s degree preferred
  • Medical device industry preferred
  • Experience with spinal implants, surgical instruments, or other mechanical systems preferred
  • Experience developing products within a regulated industry preferred

Responsibilities

  • Interface with surgeons to gather input for product designs, evaluate concepts, and translate customer feedback into design requirements
  • Collaborate effectively with R&D, Quality, Regulatory, Clinical, Marketing, and Project Management to ensure successful product development and launch
  • Design, develop, modify, evaluate, and verify components and subsystems for medical devices
  • Interpret customer needs and translate them into design inputs and product specifications
  • Develop and execute engineering activities in accordance with design control procedures and QMS requirements
  • Prepare and submit original or revised Design History File (DHF) documentation for approvals
  • Develop verification and validation strategies and execute testing to demonstrate compliance with design requirements
  • Participate in and support cadaver labs to evaluate product performance and usability
  • Develop prototypes and work closely with suppliers to evaluate designs
  • Prepare and review technical information supporting invention disclosures and patent applications
  • Present technical work and recommendations during cross-functional team meetings
  • Support transfer of products into manufacturing and commercialization activities
  • Apply sound engineering judgment to solve technical problems of moderate complexity

Benefits

  • 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
  • Potential for bonuses and incentives
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