Staff Engineer, Medical Devices - Lead R&D Projects

VB Spine, LLC; Allendale (NJ); Sur place; USD 115 000 - 125 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) with company match

Paid time off (PTO) and holidays

Ongoing training and professional dev

Growth opportunities

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Mechanical design

Creo

SolidWorks

GD&T

DFM

Regulatory design controls

Project management

Communication

Leadership

Mentoring

Formation

BS in Mechanical Engineering

MS preferred

Outils

CAE tools

Design History File management

Description du poste

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.