Senior Spine Engineering Manager – Sustaining & NPD

Highridge Medical LLC; Westminster (CO); On-site; USD 140,000 - 190,000; Full time

Job summary

Highridge Medical LLC in Westminster, Colorado seeks an experienced Sr. Engineering Manager to lead the design and lifecycle management of spine medical devices, from concept through commercialization, and to drive post-market support.

You will mentor engineers, coordinate cross-functional teams (R&D, QA, Regulatory, Manufacturing, Supply Chain), and ensure compliance with FDA QSR and ISO 13485 while optimizing cost, quality, and performance.

Qualifications

• 10+ years in design and development of spine medical devices.
• Proven leadership of engineering teams and resource management.
• Strong knowledge of post-launch lifecycle, CAPA, and design controls.
• Experience with CAD (SolidWorks) and FEA tools.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead and mentor a team of engineers and technical staff.
• Oversee design and development of spine implants and instruments.
• Ensure regulatory compliance and post-market support.
• Coordinate with R&D, QA, Regulatory, Manufacturing, and Marketing.
• Drive continuous improvement and cost optimization.

Skills

Leadership

Project management

Cross-functional collaboration

CAD (SolidWorks)

Finite element analysis

Communication

Education

B.S. Mechanical Engineering

B.S. Biomedical Engineering

MS or PhD preferred

Tools

SolidWorks

FEA tools

Job description

Highridge Medical LLC in Westminster, Colorado seeks an experienced Sr. Engineering Manager to lead the design and lifecycle management of spine medical devices, from concept through commercialization, and to drive post-market support.

You will mentor engineers, coordinate cross-functional teams (R&D, QA, Regulatory, Manufacturing, Supply Chain), and ensure compliance with FDA QSR and ISO 13485 while optimizing cost, quality, and performance.