Spinal Implant Engineering Lead

Nexxt Spine, LLC; Noblesville (IN); Presencial; USD 120.000 - 165.000; Jornada completa

Descripción de la vacante

Nexxt Spine, LLC, a leader in spinal implants and instruments, seeks an Engineering Manager to translate surgeon concepts into defined scope and deliverables. You will guide the engineering ladder from Engineer I to Lead Engineer, ensuring phase gates, regulatory milestones, and production transfers are met.

In this role you will own project plans, coordinate FDA testing, and manage cross-functional teams to deliver compliant, high-quality implants and instruments on schedule.

Formación

• Experience taking implants or instruments from concept through 510(k) clearance and production release.
• Supervisory or project leadership over engineers at multiple levels.
• Knowledge of FDA design controls, GMP, ISO 13485, and DHF requirements.
• Proficiency with project planning tools, schedules, phase gates, and risk logs.
• Hands-on understanding of SolidWorks, additive manufacturing, and ASTM testing.
• Clear written and verbal communication across levels.
• Strong analytical and problem-solving skills for trade-offs.

Responsabilidades

• Translate surgeon concepts into defined project charters and scope.
• Own plan from concept to 510(k) clearance and production release.
• Supervise engineers from entry to lead roles and set milestones.
• Publish a single source of project status for stakeholders.
• Coordinate phase gates and exit criteria for project progression.

Conocimientos

Project management

Leadership

FDA design controls

Regulatory planning

SolidWorks

Additive manufacturing

Problem solving

Communication

Educación

Bachelor of Science in Engineering

Herramientas

SolidWorks

3D Printing

Mechanical testing

Descripción del empleo

Nexxt Spine, LLC, a leader in spinal implants and instruments, seeks an Engineering Manager to translate surgeon concepts into defined scope and deliverables. You will guide the engineering ladder from Engineer I to Lead Engineer, ensuring phase gates, regulatory milestones, and production transfers are met.

In this role you will own project plans, coordinate FDA testing, and manage cross-functional teams to deliver compliant, high-quality implants and instruments on schedule.