Staff Engineer

VB Spine, LLC; Allendale (NJ); On-site; USD 115,000 - 125,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off (PTO) and holidays

Ongoing training and professional dev

Growth opportunities

Job summary

VB Spine, LLC in New Jersey is seeking a skilled Mechanical Engineer to design, develop, modify, and verify medical device components and subsystems. You will lead large projects, work with cross-functional teams, and apply DFM principles within a regulated environment.

The position requires a BS in Mechanical or Biomedical Engineering, 4+ years of experience, and strong CAD (Creo or SolidWorks) abilities with GD&T and design controls.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field; Master’s preferred.
• 4+ years of relevant work experience in mechanical design for medical devices.
• Strong CAD skills with Creo or SolidWorks and proficiency in GD&T and CAE tools.

Responsibilities

• Interface with surgeons and sales reps to gather input for design and evaluation of enhancements.
• Independently design and verify mechanical components and subsystems for medical devices.
• Lead large projects and cross-functional design teams (R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, PM).
• Lead design reviews and develop/design History Files, Change Control, CAPA records, and Regulatory docs.
• Translate user needs into design inputs and system-level designs; conduct prototyping and testing.
• Mentor others on design controls, risk management, and QMS requirements.
• Apply materials and manufacturing knowledge to improve DFMs and manufacturability.

Skills

Mechanical design

Creo

SolidWorks

GD&T

DFM

Regulatory design controls

Project management

Communication

Leadership

Mentoring

Education

BS in Mechanical Engineering

MS preferred

Tools

CAE tools

Design History File management

Job description

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

Why VB Spine?

We believe in growing talent from within. At VB Spine, join a high-performing R&D team where you’ll play a critical role in sustaining and evolving innovative spinal implants and instruments that improve patient lives.

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