Sr. Sustaining Engineering Manager

Highridge Medical LLC; Westminster (CO); On-site; USD 140,000 - 190,000; Full time

Job summary

Highridge Medical LLC in Westminster, Colorado seeks an experienced Sr. Engineering Manager to lead the design and lifecycle management of spine medical devices, from concept through commercialization, and to drive post-market support.

You will mentor engineers, coordinate cross-functional teams (R&D, QA, Regulatory, Manufacturing, Supply Chain), and ensure compliance with FDA QSR and ISO 13485 while optimizing cost, quality, and performance.

Qualifications

• 10+ years in design and development of spine medical devices.
• Proven leadership of engineering teams and resource management.
• Strong knowledge of post-launch lifecycle, CAPA, and design controls.
• Experience with CAD (SolidWorks) and FEA tools.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead and mentor a team of engineers and technical staff.
• Oversee design and development of spine implants and instruments.
• Ensure regulatory compliance and post-market support.
• Coordinate with R&D, QA, Regulatory, Manufacturing, and Marketing.
• Drive continuous improvement and cost optimization.

Skills

Leadership

Project management

Cross-functional collaboration

CAD (SolidWorks)

Finite element analysis

Communication

Education

B.S. Mechanical Engineering

B.S. Biomedical Engineering

MS or PhD preferred

Tools

SolidWorks

FEA tools

Job description

Sr. Engineering Manager 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 an experienced Engineering Manager to lead our dynamic engineering team in the development and lifecycle management of innovative spine medical devices. The Engineering Manager will play a pivotal role in driving the design, development, commercialization, and post-production support of existing and next-generation spinal implants and instrumentation. This role will manage both new product development engineers responsible for the design and development of new products and sustaining engineers responsible for the technical support, maintenance, and continuous improvement of released products. This position offers an exciting opportunity to collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, Supplier Quality, Marketing, and Sales, to bring novel solutions to market and maintain product performance, compliance, and availability throughout the product lifecycle.

Principal Duties and Responsibilities

• Lead and mentor a team of engineers and technical staff, fostering a culture of innovation, collaboration, and excellence.
• Manage and develop new product development and sustaining engineers responsible for released spinal implants, instruments, and systems, including workload prioritization, project assignment, coaching, performance development, and technical oversight.
• Oversee the sustaining engineering task lists from issue definition through implementation and closure, balancing product-development priorities with post-market, production-continuity, quality, regulatory, and business needs.
• Ensure the team effectively evaluates complaints, and leads or supports root cause investigations and development-related CAPAs; and implements compliant engineering changes.
• Provide oversight for post-launch design controls, risk-management documentation, product and process evaluations, verification and validation, test method validation, process validation, supplier changes, component obsolescence, alternate-source qualification, and production transfers, as applicable.
• Establish priorities, metrics, and operating practices for engineering teams that improve timely closure, product availability, quality, manufacturability, reliability, cost, and regulatory compliance.
• Oversee the design and development of spine medical devices from concept through commercialization, ensuring adherence to project timelines, budget constraints, and regulatory requirements.
• Provide technical guidance and expertise in the areas of mechanical design, materials selection, manufacturing processes, and product testing.
• Collaborate closely with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to address technical challenges, resolve issues, and optimize product performance.
• Drive continuous improvement initiatives to enhance product quality, reliability, and cost-effectiveness.
• Develop and maintain design control documentation, including design input requirements, risk assessments, verification and validation protocols, and technical reports.
• Stay abreast of industry trends, emerging technologies, and regulatory standards relevant to spine medical devices.
• Designs or directs design work for manufacturability, inspectability and optimum cost
• Conducts or participates in root cause analysis for problem solving
• Contributes to generation of a comprehensive protocol for testing/analyzing the product
• Coordinating product evaluation and establishing user needs directly with surgeon

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)

• Proven track record of successfully leading engineering teams and delivering complex projects on time and within budget.
• Demonstrated ability to lead projects, engineering teams, develop engineers, allocate resources, manage competing priorities, and maintain accountability for timely, compliant execution.
• Strong working knowledge of the post-launch medical device lifecycle, including change control, nonconformance and complaint evaluation, CAPA, design controls, risk management, production support, supplier changes, verification and validation, and product obsolescence.
• Strong technical expertise in mechanical design, materials science, and manufacturing processes relevant to medical devices.
• In-depth knowledge of regulatory requirements and quality standards applicable to spine medical devices (e.g., FDA QSR, ISO 13485).
• Knowledge of medical device manufacturing documentation for product release.
• Excellent communication, leadership, and interpersonal skills, with the ability to collaborate effectively across functional teams and external customers.
• Experience with CAD software (e.g., SolidWorks) and finite element analysis (FEA) tools preferred.
• Prior experience in the spine industry and familiarity with relevant anatomical considerations and surgical techniques is a plus.
• Candidate must have demonstrated self-directed working capabilities.
• Demonstrate ability to methodically investigate and resolve problems using current technology.
• Knowledge of project management tools.
• Comfortable working in a fast paced, cross disciplinary environment.
• Able to work with minimal direction towards completing project tasks.
• Demonstrated good written and verbal communication skills including presentation skills.
• Leads or participates in the creation and improvement of processes.

Microsoft Office Suite and Project Education/Experience Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field; advanced degree (MS or PhD) preferred.
• Minimum of 10 years of experience in the design and development of spine medical devices or orthopedic implants and management of engineering resources Experience leading or managing sustaining engineering activities and engineers for released medical devices is preferred.

Travel Requirements Up To 20%

Salary Range $160,000-