Senior Spine Sustaining Engineer, Post-Launch

HIGHRIDGE Inc.; Westminster (CO); On-site; USD 85,000 - 100,000; Full time

Job summary

Highridge Medical is seeking a Sr. Sustaining Engineer I to maintain post-market spinal implants and instruments through the product lifecycle. The role partners with Quality, Regulatory, Manufacturing, and Supply Chain to resolve issues and implement compliant design changes.

You will update CAD models (SolidWorks), lead root-cause investigations, and support post-launch documentation, risk analyses, and regulatory filings, while mentoring junior engineers as needed.

Qualifications

• Minimum B.S. in an ABET-accredited engineering program.
• 3-7 years of relevant engineering experience in medical devices.
• Experience with orthopaedic implants and instruments preferred.
• Experience developing spine or other medical devices preferred.

Responsibilities

• Lead sustaining projects from issue to closure.
• Provide day-to-day technical support to Manufacturing, Quality, Supply Chain, and suppliers to maintain product availability.
• Review nonconforming product, customer complaints, field returns, scrap, yield loss, and process variability; provide dispositions and recommendations.
• Lead or support root cause investigations and CAPAs using structured problem solving and statistics.

Skills

Root cause analysis

Sustaining engineering

CAD design

SolidWorks

Design for manufacturability

Statistical methods

Documentation & regulatory

Education

ABET-accredited BS in Mechanical Engineering

Biomedical/BME acceptable

Tools

SolidWorks

MS Office

Project tracking tools

Job description

Highridge Medical is seeking a Sr. Sustaining Engineer I to maintain post-market spinal implants and instruments through the product lifecycle. The role partners with Quality, Regulatory, Manufacturing, and Supply Chain to resolve issues and implement compliant design changes.

You will update CAD models (SolidWorks), lead root-cause investigations, and support post-launch documentation, risk analyses, and regulatory filings, while mentoring junior engineers as needed.