Sr. Sustaining Engineer I

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 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. Principal Duties and 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, 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 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.· 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. Expected Areas of Competence (i.e., knowledge, skills, and abilities) · 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 develop and maintain project schedules, balance multiple priorities, and drive cross-functional tasks to completion with limited supervision.· Strong working knowledge of manufacturing processes, inspection methods, design for manufacturability, and continuous-improvement principles for machined or manufactured medical devices.· Proficient in CAD design and engineering drawings, preferably using SolidWorks, with working knowledge of drafting standards and GD&T.· Familiarity with FDA Quality System requirements, ISO 13485, ISO 14971, and other regulations and standards applicable to orthopedic medical devices.· Ability to analyze data, identify trends, and use structured problem-solving tools; familiarity with Lean, Six Sigma, DOE, SPC, capability analysis, or statistical software is preferred.· Professional, concise, and tactful communication with internal teams and external stakeholders, including suppliers, test laboratories, surgeons, and regulatory partners.· Proficient with Microsoft Office Suite and project-tracking tools; able to create clear technical reports and present recommendations to cross-functional teams and leadership.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.· 3-7 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 RequirementsUp to 10%Salary Range $85,000.00- 100,000.00 DOE