Hybrid Project Engineer, Medical Devices R&D

VB Spine, LLC; New Jersey; Hybrid; USD 90,000 - 110,000; Full time

Job summary

VB Spine is seeking a Project Engineer to join our R&D team in the Spine division. You will interface with surgeons, translate their input into design specs, and lead small projects to advance implant and instrument designs for commercially available products.

You will collaborate across R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management while contributing to design reviews, documentation, and regulatory files.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 2+ years of relevant work experience.
• Working knowledge of mechanical engineering practices and design principles.
• Ability to create engineering drawings and models using GD&T and CAE tools.
• Experience with a parametric CAD package (Creo or SolidWorks preferred).
• Familiarity with design controls within a regulated industry.
• Basic project management skills to lead small projects.
• Good technical communication skills.
• Ability to work with a medium level of supervision while providing input.

Responsibilities

• Interface with surgeons to gather input for design and evaluation of new and existing products.
• Develop innovative solutions that meet customer needs based on surgical procedures.
• Design, develop, modify, evaluate, and verify mechanical components for medical devices.
• Collaborate with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and PM teams to ensure project success.
• Participate in and lead design reviews and change control initiatives.
• Create and refine engineering documentation including Design History Files and CAPA records.
• Translate design inputs into specifications and sub-system level designs.
• Develop prototypes and proof of concept analyses.
• Follow design controls, risk management, and NC/CAPA procedures.
• Demonstrate understanding of customer needs and clinical applications.
• Contribute to technical and cultural growth of the organization.
• Work as a key team member with ownership and prioritization.

Skills

Surgeon interface

Strong design sense

Mechanical design

GD&T knowledge

CAEs/tools

Education

Bachelor of Science in Mechanical Engineering

Master’s degree preferred

Tools

Creo

SolidWorks

GD&T

Job description

VB Spine is seeking a Project Engineer to join our R&D team in the Spine division. You will interface with surgeons, translate their input into design specs, and lead small projects to advance implant and instrument designs for commercially available products.

You will collaborate across R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management while contributing to design reviews, documentation, and regulatory files.