VB Spine · 4 days ago
Staff Design Quality Engineer
Allendale, NJ
Full-time
Hybrid
Senior Level, Lead/Staff
$105K/yr - $135K/yr
5+ years expVB Spine is a mission-focused company that supports surgeons during life-changing spinal procedures. As a Staff Design Quality Engineer, you will ensure design excellence in new product development and drive quality throughout the product lifecycle.
E-CommerceHospitalManufacturingMedical Device
Responsibilities
Act as the lead Quality Assurance representative on cross-functional new product development (NPD) teams
Collaborate with technical experts in R&D, Process Development, Regulatory Affairs, Marketing, and Project Management to define design requirements and develop manufacturing processes for new product development
Lead risk management activities and develop risk management plans and reports for product and process quality
Create and maintain quality assurance documentation to support product development and regulatory submissions
Identify and address gaps in design control processes and procedures
Participate in design reviews to evaluate product risks and mitigation strategies
Define and support design verification and validation test requirements and reports
Promote efficient and statistically valid testing practices
Support the definition of critical quality attributes and risk-based product evaluations
Facilitate product design transfers to internal or external manufacturing
Analyze feedback from early product launches and address quality issues
Perform health risk assessments for post-market events
Use tools such as FMEA, Root Cause Analysis, and GD&T for continuous improvement
Interact with regulatory agencies and support audits and submissions
Qualification
Required
Bachelor's degree in science, engineering, or related discipline required
Minimum 5 years of experience in medical device or other regulated industries
Knowledge of design and process verification and validation in product development
Expertise with quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing
Proficiency in reading and interpreting CAD drawings
Experience with US and international medical device regulations and agency interactions (e.g., FDA, TUV, MoH)
Strong foundation in quality concepts such as CAPA, audits, and statistics
Ability to manage multiple projects in a matrixed organization
Strong problem-solving, critical thinking, and communication skills
Experience working in compliance and risk assessment scenarios
Proficiency with Microsoft Office and statistical analysis tools (e.g., Minitab)
Preferred
MS, Certified Quality Engineer (CQE), or Certified Reliability Engineer (CRE) preferred
Six Sigma Green or Black Belt preferred
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
Company
VB Spine
VB Spine provides spine implants and spinal solutions for surgical procedures and patient care.
1001-5000 employees
Funding
Current Stage
Late StageRecent News
2026-01-06
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