Engrg Manager

HighRidge Medical LLC-posted 2 months ago
Full-time • Mid Level
Westminster, CO
1,001-5,000 employees
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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.

  • 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 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.
  • 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., 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.
  • Advanced degree (MS or PhD) preferred.
  • Managerial experience preferred.
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