Senior Spine Sustaining Engineer: Post-Launch Impact

HIGHRIDGE Inc.; Westminster, Northern (CO, KY); Hybrid; USD 85,000 - 100,000; Full time

Job summary

Highridge Medical seeks a Senior Sustaining Engineer to maintain post-production spinal implants and instruments, drive design changes, and support cross-functional teams. You will lead investigations, CAPAs, and product evaluations while updating CAD models and ensuring regulatory compliance.

Responsibilities include day-to-day manufacturing support, risk management, and post-market documentation. Travel up to 10% and a DOE environment are expected, with a focus on quality, reliability, and

Qualifications

• BS in Mechanical or Biomedical Engineering from an ABET-accredited program.
• 3–7 years of relevant medical device sustaining engineering experience.
• Experience with implants/instruments preferred.
• Strong CAD/drawing skills, SolidWorks and GD&T.

Responsibilities

• Leads sustaining engineering projects for released spinal implants, instruments, and production-transferred parts from issue definition through implementation and closure.
• Provides day-to-day technical support to Manufacturing, Quality, Supply Chain, and suppliers to maintain product availability.
• Reviews nonconforming product, customer complaints, field returns, scrap, yield loss, and process variability with dispositions.
• Leads root cause investigations and CAPAs using structured problem-solving, risk-based decision making, and appropriate statistical methods.
• Updates CAD models and engineering drawings, primarily in SolidWorks, and applies GD&T and design-for-manufacturability, inspectability, reliability, and cost principles.
• Plans and executes product and process evaluations, design verification and validation, test method validation, and manufacturing process validation, as applicable; authors protocols, reports, and technical justifications.
• Maintains and remediates post-launch design control and risk-management documentation, including DHF and technical-file records, risk analyses, inspection plans, protocols, and reports.
• Supports post-market surveillance and regulatory activities by supplying technical assessments and documentation for global registrations, field actions, and product lifecycle decisions.

Skills

Root cause analysis

CAPA process

Sustaining engineering

Risk management

Lean Six Sigma

Education

Bachelor's degree in Mechanical Engineering

ABET-accredited program in Mechanical/Biomedical Engineering

Tools

SolidWorks

GD&T

Job description

Highridge Medical seeks a Senior Sustaining Engineer to maintain post-production spinal implants and instruments, drive design changes, and support cross-functional teams. You will lead investigations, CAPAs, and product evaluations while updating CAD models and ensuring regulatory compliance.

Responsibilities include day-to-day manufacturing support, risk management, and post-market documentation. Travel up to 10% and a DOE environment are expected, with a focus on quality, reliability, and