Sustaining Sr Engineer II 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 Sustaining Senior Engineer II responsible for the technical leadership, maintenance, and continuous improvement of post-production spinal implants, instruments, and systems throughout the product lifecycle. This engineer independently leads large-scope, complex sustaining projects and cross-functional investigations with minimal guidance, makes high-impact technical and risk-based decisions, and provides direction across multiple concurrent priorities. The role partners with Quality, Regulatory, Manufacturing, Supply Chain, Supplier Quality, Testing, Marketing, and Sales to resolve complex product and production issues, implement compliant design and documentation changes, maintain product performance and availability, and improve quality, manufacturability, reliability, and cost. Regular interaction with suppliers and external test laboratories, occasional interaction with surgeons, and mentoring of junior engineers are expected.
Principal Duties and Responsibilities:
· Leads large-scope and complex sustaining engineering projects for released spinal implants, instruments, and production-transferred parts, from issue definition and risk assessment through implementation and closure.
· Provides technical leadership to Manufacturing, Quality, Supply Chain, and suppliers to maintain product availability, quality, and production continuity, including resolution of high-priority or escalated issues.
· Leads evaluation of nonconforming product, customer complaints, field returns, scrap, yield loss, and process variability; makes technically sound, risk-based dispositions and recommendations with significant product or business impact.
· Leads complex root cause investigations and development-related CAPAs using structured problem-solving, risk-based decision making, and appropriate statistical methods; ensures corrective actions are effective and sustainable.
· Creates and approves Engineering Change Requests/Orders through completion, including updates to specifications, drawings, bills of material, inspection requirements, labeling, work instructions, and related records.
· Creates and reviews complex CAD models and engineering drawings, primarily in SolidWorks, and applies advanced GD&T and design-for-manufacturability, inspectability, reliability, and cost principles.
· Defines strategy and leads product and process evaluations, design verification and validation, test method validation, and manufacturing process validation, as applicable; authors and approves protocols, reports, and technical justifications.
· Leads remediation and maintenance of post-launch design control and risk-management documentation, including DHF and technical-file records, risk analyses, inspection plans, protocols, and reports.
· Provides technical leadership for post-market surveillance and regulatory activities, including technical assessments and documentation supporting global registrations, field actions, and product lifecycle decisions.
· Reviews and provides engineering input on clinical, scientific, and technical documentation supporting product safety and performance, regulatory submissions, post-market activities, and product lifecycle decisions.
· Identifies, prioritizes, and implements product, supplier, and manufacturing improvements that reduce risk, scrap, cycle time, and cost while maintaining validated performance and regulatory compliance.
· Leads technical work with suppliers, contractors, and test laboratories; directs supplier changes, component obsolescence, alternate-source…