Sustaining Sr Engineer II

Highridge Medical•Westminster, CO

3d•$100,000 - $120,000

About The Position

Highridge Medical is seeking a Sustaining Senior Engineer II to provide technical leadership, maintenance, and continuous improvement for post-production spinal implants, instruments, and systems throughout the product lifecycle. The engineer independently leads large-scope, complex sustaining projects and cross-functional investigations with minimal guidance, makes high-impact technical and risk-based decisions, and manages 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. The position leads sustaining projects from issue definition and risk assessment through implementation and closure; evaluates product and process issues; conducts root-cause investigations and CAPAs; and creates and approves engineering changes and related documentation. It also leads product and process evaluations, verification and validation activities, design-control and risk-management documentation maintenance, and technical support for post-market surveillance and regulatory activities. The engineer manages project plans, priorities, timelines, resources, risks, and cross-functional actions, while providing technical direction and mentoring. Travel is up to 10%. Salary range is $100,000–$120,000 DOE.

Requirements

B.S. degree from an ABET-accredited school or global equivalent in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering, or Aeronautical Engineering.
At least 7 years of relevant engineering experience.
Advanced working knowledge of the post-launch medical device lifecycle, design controls, risk management, change control, production transfer, and global regulatory requirements.
Ability to independently lead investigations of complex technical problems, determine root cause, assess product and patient risk, and implement corrective actions across functional teams.
Experience evaluating complaints, nonconforming product, manufacturing trends, and supplier issues and translating findings into engineering and business recommendations.
Ability to plan, execute, and document verification, validation, product evaluation, test method validation, and process-validation activities using objective evidence and statistical methods.
Ability to 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, with advanced knowledge of drafting standards and GD&T.
Ability to ensure product and process compliance with FDA Quality System requirements, ISO 13485, ISO 14971, and other applicable orthopedic medical-device regulations and standards.
Ability to critically review clinical, scientific, and technical documentation for accuracy, consistency, traceability, and alignment with product requirements, risk-management records, objective evidence, and applicable standards.
Ability to lead data analysis and trend evaluation using structured problem-solving and statistical tools.
Professional, concise, tactful, and influential communication with internal teams and external stakeholders.
Proficiency with Microsoft Office Suite and project-tracking tools, including the ability to create technical reports, communicate project metrics, and present recommendations to technical and executive audiences.

Nice To Haves

Experience in medical-device sustaining engineering, manufacturing engineering, product development, or lifecycle management.
Experience with orthopedic implants and instruments.
Experience developing spine or other medical devices, including implants and instruments.
Experience with SolidWorks.
Experience with Lean, Six Sigma, DOE, SPC, capability analysis, or statistical software.

Responsibilities

Lead 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.
Provide 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.
Lead evaluations of nonconforming product, customer complaints, field returns, scrap, yield loss, and process variability; make risk-based dispositions and recommendations.
Lead complex root-cause investigations and development-related CAPAs, using structured problem-solving and appropriate statistical methods, and ensure corrective actions are effective and sustainable.
Create and approve Engineering Change Requests and Orders, including changes to specifications, drawings, bills of material, inspection requirements, labeling, work instructions, and related records.
Create and review complex CAD models and engineering drawings, primarily in SolidWorks, applying advanced GD&T and design-for-manufacturability, inspectability, reliability, and cost principles.
Define strategy and lead product and process evaluations, design verification and validation, test method validation, and manufacturing process validation as applicable; author and approve protocols, reports, and technical justifications.
Lead 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.
Provide technical leadership for post-market surveillance and regulatory activities, including technical assessments and documentation supporting global registrations, field actions, and product lifecycle decisions.
Review and provide engineering input on clinical, scientific, and technical documentation supporting product safety and performance, regulatory submissions, post-market activities, and lifecycle decisions.
Identify, prioritize, and implement product, supplier, and manufacturing improvements that reduce risk, scrap, cycle time, and cost while maintaining validated performance and regulatory compliance.
Lead technical work with suppliers, contractors, and test laboratories; direct supplier changes, component obsolescence, alternate-source qualification, and production transfers.
Create project plans, set priorities, manage timelines and resources, communicate risks and status to technical and leadership audiences, and drive cross-functional actions to timely closure.
Provide technical direction and mentor engineers or technicians on sustaining engineering methods, documentation, investigations, and engineering judgment.