Engrg Manager

Engineering Manager – Highridge Medical – Littleton, CO

We are seeking an experienced Engineering Manager to lead our dynamic engineering team in the development of innovative spine medical devices. The Engineering Manager will play a pivotal role in driving the design, development, and commercialization of next‑generation spinal implants and instrumentation. This position offers an exciting opportunity to collaborate with cross‑functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to bring novel solutions to market.

$/yr – $/yr

• Lead and mentor a team of engineers and technical staff, fostering a culture of innovation, collaboration, and excellence.
• 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 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.
• Design or direct design work for manufacturability, inspectability, and optimum cost.
• Conduct root cause analysis for problem solving.
• Contribute to the generation of a comprehensive protocol for testing/analyzing the product.
• Coordinate product evaluation and establish user needs directly with surgeons.

• Proven track record of successfully leading engineering teams and delivering complex projects on time and within budget.
• 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., Solid Works) 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.
• 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.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field; advanced degree (MS or PhD) preferred.
• Minimum of 7 years of experience in the design and development of spine medical devices or orthopedic implants. Managerial experience preferred.

Up to 20%.

Mid‑Senior level.

Full‑time.

Other.

Medical Equipment Manufacturing.

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