Bachelor's degree in Mechanical or Biomedical Engineering; Master's preferred
2+ years of experience in medical device industry
Familiarity with spinal implants or surgical instruments
Knowledge of FDA design controls and ISO standards
Proficient in CAD software (SolidWorks or Creo)
Experience in developing design requirements and verification plans
Strong communication skills and ability to manage multiple tasks
Responsibilities
Interface with surgeons to gather product design input
Collaborate with cross-functional teams for product development
Design and evaluate components for medical devices
Translate customer needs into product specifications
Develop engineering activities per design control procedures
Prepare Design History File documentation for approvals
Execute testing to demonstrate compliance with design requirements
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 for growth in a dynamic company
Full Job Description
Senior Development Engineer - PRO Team
Location: Leesburg, VA (Up to 15% Travel Required)
Company: VB Spine
What You'll Do:
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
What You Bring:
Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or related engineering discipline (Master's degree preferred)
2+ years of experience required; medical device industry preferred
Experience with spinal implants, surgical instruments, or other mechanical systems preferred
Experience developing products within a regulated industry preferred
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
Compensation:
Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $105,000.00 - $135,000.00 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
