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Westminster, Colorado, United States
Onsite
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 qualification, and production transfers.
· Creates project plans, sets priorities, manages timelines and resources, communicates risks and status to technical and leadership audiences, and drives cross-functional actions to timely closure.
· Provides technical direction and mentors engineers or technicians on sustaining engineering methods, documentation, investigations, and sound engineering judgment.
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.
Expected Areas of Competence (i.e., knowledge, skills, and abilities)
· Advanced working knowledge of the post-launch medical device lifecycle, design controls, risk management, change control, production transfer, and global regulatory requirements.
· Demonstrated ability to independently lead investigation of complex technical problems, determine root cause, assess product and patient risk, and implement robust corrective actions across functional teams.
· Advanced experience evaluating complaints, nonconforming product, manufacturing trends, and supplier issues and translating findings into clear engineering and business recommendations.
· Ability to define strategy and independently plan, execute, and document verification, validation, product evaluation, test method validation, and process-validation activities using objective evidence and sound statistical methods.
· Ability to create and manage schedules for multiple complex projects, set priorities, anticipate risks, and drive cross-functional tasks to completion with minimal guidance.
· Advanced knowledge of manufacturing processes, inspection methods, design for manufacturability, and continuous-improvement principles for machined or manufactured medical devices.
· Expertise in CAD design and engineering drawings, preferably using SolidWorks, with advanced knowledge of drafting standards and GD&T.
· Demonstrated ability to ensure product and process compliance with FDA Quality System requirements, ISO 13485, ISO 14971, and other regulations and standards applicable to orthopedic medical devices.
· Ability to critically review clinical, scientific, and technical documentation for technical accuracy, consistency, traceability, and alignment with product requirements, risk-management records, objective evidence, and applicable regulatory standards.
· Ability to lead data analysis and trend evaluation using structured problem-solving and statistical tools; experience with Lean, Six Sigma, DOE, SPC, capability analysis, or statistical software is preferred.
· Professional, concise, tactful, and influential communication with internal teams and external stakeholders, including suppliers, test laboratories, surgeons, regulatory partners, and senior leadership.
· Proficient with Microsoft Office Suite and project-tracking tools; able to create clear technical reports, communicate project metrics, and present recommendations to technical and executive audiences.
Education/Experience Requirements
· Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.
· 7+ years of relevant engineering experience, preferably in medical device sustaining engineering, manufacturing engineering, product development, or lifecycle management; experience with orthopaedic implants and instruments is preferred.
· Preferred: Experience developing spine or other medical devices, including implants and instruments.
Travel Requirements
Up to 10%
Salary Range $100,000- $120,000 DOE
