Senior Sustaining Engineer II: Spine Implants & Instruments

Highridge Medical LLC; Westminster (CO); On-site; USD 100,000 - 120,000; Full time

Job summary

Highridge Medical LLC in Westminster, CO is seeking a Sustaining Senior Engineer II to lead post-launch activities for spinal implants and instruments, ensuring reliability, quality, and regulatory compliance. You will guide cross-functional teams through issue resolution, design changes, and risk management across the product lifecycle.

The role requires strong technical leadership, root cause analysis, and collaboration with suppliers and manufacturing to maintain product availability and cost

Qualifications

• Minimum B.S. in Mechanical or Biomedical Engineering.
• 7+ years in medical device sustaining or manufacturing.
• Experience with orthopaedic implants or instruments preferred.
• Experience with design controls and post-launch activities.

Responsibilities

• Lead large-scope sustaining projects for released spinal implants and instruments.
• Provide technical leadership to manufacturing, quality, supply chain, and suppliers.
• Lead root cause investigations and CAPA activities with risk-based dispositions.
• Create and approve engineering changes, drawings, BOMs, and verification records.
• Perform design reviews and document verification, validation, and process validation.
• Mentor junior engineers and coordinate cross-functional teams for timely closure.

Skills

Technical leadership

Cross-functional collaboration

Risk-based decision making

Statistical analysis

Root cause analysis

Education

Bachelor's degree in Mechanical/Biomedical Engineering

Tools

SolidWorks

MS Office

Job description

Highridge Medical LLC in Westminster, CO is seeking a Sustaining Senior Engineer II to lead post-launch activities for spinal implants and instruments, ensuring reliability, quality, and regulatory compliance. You will guide cross-functional teams through issue resolution, design changes, and risk management across the product lifecycle.

The role requires strong technical leadership, root cause analysis, and collaboration with suppliers and manufacturing to maintain product availability and cost