Sr. Sustaining Engineer

Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Complex Deformity to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves.

We are seeking a Senior I Sustaining Engineer responsible for the technical support, maintenance, and continuous improvement of post-production spinal implants, instruments, and systems throughout the product lifecycle. This engineer leads small- to medium-scope sustaining projects with increasing autonomy and serves as a technical contributor on larger cross-functional efforts. The role partners with Quality, Regulatory, Manufacturing, Supply Chain, Supplier Quality, Testing, Marketing, and Sales to resolve product and production issues, implement compliant design and documentation changes, maintain product performance and availability, and improve quality, manufacturability, reliability, and cost.

Occasional interaction with surgeons, suppliers, and external test laboratories, as well as mentoring of junior engineers, may be required.

• 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, quality, and production continuity.
• Reviews and evaluates nonconforming product, customer complaints, field returns, scrap, yield loss, and process variability; provides technically sound dispositions and recommendations.
• Leads or supports root cause investigations and development-related CAPAs using structured problem-solving, risk-based decision making, and appropriate statistical methods.
• Creates and manages Engineering Change Requests/Orders through completion, including updates to specifications, drawings, bills of material, inspection requirements, labeling, work instructions, and related records.
• Updates CAD models and engineering drawings, primarily in Solid Works, 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.
• Identifies and implements product, supplier, and manufacturing improvements that reduce risk, scrap, cycle time, and cost while maintaining validated performance and regulatory compliance.
• Coordinates technical work with suppliers, contractors, and test laboratories; supports supplier changes, component obsolescence, alternate-source qualification, and production transfers.
• Develops project plans, manages priorities and timelines, communicates risks and status, and drives cross-functional actions to timely closure.
• Provides technical guidance and may mentor junior engineers or technicians on sustaining engineering methods, documentation, and investigations.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

• Working knowledge of the post-launch medical device lifecycle, design controls, risk management, change control, and production-transfer requirements.
• Demonstrated ability to independently investigate technical problems, determine root cause, assess risk, and implement effective corrective actions.
• Experience evaluating complaints, nonconforming product, manufacturing trends, and supplier issues and translating findings into clear engineering decisions.
• Ability to plan and document verification, validation, product evaluation, and process-validation activities using objective evidence and sound statistical methods.
• Ability to…