Sr. Sustaining Engineering Manager

HIGHRIDGE Inc.; Westminster, Northern (CO, KY); Hybrid; USD 160,000 - 185,000; Full time

Job summary

Highridge Medical is seeking an experienced Engineering Manager to lead our spinal implants and instrumentation development and lifecycle management.

You will guide sustaining and development engineers, collaborate with R&D, QA, regulatory, manufacturing, and supply chain, and drive design controls, risk management, verification and validation, and post-market support.

Qualifications

• 10+ years in design and development of spine/orthopedic devices.
• Experience leading sustaining engineering and released devices teams.
• Strong knowledge of design controls, risk management, verification/validation, and approvals.

Responsibilities

• Lead and mentor engineering teams to deliver complex spine devices on time and within budget.
• Oversee post-launch design controls, risk management, and change control processes.
• Coordinate cross-functional efforts with R&D, QA, Regulatory, Manufacturing, and Supply Chain.
• Drive continuous improvement in product quality, reliability, and cost-effectiveness.
• Manage workload, coaching, performance development, and technical oversight of engineers.
• Ensure compliance with FDA QSR, ISO 13485 and applicable standards.

Skills

Engineering leadership

Project management

CAD SolidWorks

Regulatory knowledge

Education

Bachelor's in Mechanical Eng

MS/PhD preferred

Tools

SolidWorks

FEA software

Job description

Sr. Sustaining Engineering ManagerHighridge 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 surgeonThis 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 RequirementsUp to 20% Salary Range $160,000- 185,000 DOE