HighRidge Medical LLC

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We are seeking a Development Principal Engineer responsible for the design and development of spinal implants and instruments. This individual will lead large-scope, cross-functional projects with minimal guidance and support both new product development and sustaining engineering. The engineer is expected to interact directly with surgeons and cross-functional stakeholders such as Marketing, Regulatory, Quality, Testing, and Sales. In the role they should also demonstrate initiative, strong technical leadership, and the ability to make high-level design decisions that impact implant and instrument systems across spinal procedures. Occasional travel and mentoring of junior engineers is expected. Principal Duties and Responsibilities - Leads the design and development of new products and improvements to existing products from conception to launch following Design Control procedures. - Leads the creation of project plans and manages critical project timelines. - Leads the development of innovative, clinically driven solutions by anticipating surgical needs and identifying unmet opportunities, transforming concepts into commercialized implant and instrument systems. - Collects customer (surgeon) feedback and defines user needs, specifications, and performance criteria. - Generates CAD models and engineering drawings primarily within Solidworks. - Designs complex mechanisms/instrumentation and implements advanced design principles. - Authors and maintains design control documentation within a DHF. - Leads test strategy development and contributes to test protocol/report creation. - Defines and executes verification and validation activities with support from testing and quality teams. - Designs components for manufacturability, inspectability, and cost-effectiveness. - Ability to lead large scale projects while also managing multiple smaller projects throughout all states of the development process. - Leads and/or participates in root cause investigations and corrective actions. - Creates comprehensive protocols and reports for ASTM testing or evaluation of products. - Creates invention disclosures and IP generation. Expected Areas of Competence - Full working knowledge (advanced level of experience) with new product development, including design control, regulatory compliance, and cross-functional execution. - Demonstrated ability to independently investigate complex problems, develop robust solutions, and lead their implementation across functional teams. - Ability to create and manage project schedules, proactively drive cross-functional progress, and adjust plans to meet strategic objectives. - Ability to lead resolution of customer complaints, drive engineering change requests, manage nonconforming product, and make recommendations based upon business principles. - Professional, concise, tactful, and effective in communications. Influences and aligns internal teams and external stakeholders including surgeons and vendors. - Strong written and verbal communication skills, including preparation and delivery of presentations tailored to technical and executive audiences. - Advanced working knowledge of drafting standards and geometric dimensioning and tolerancing (GD&T). - Demonstrated ability to ensure product and process compliance with applicable Quality Assurance and Regulatory requirements in the medical device industry. - Ability to manage and set priorities for multiple complex projects and deliverables concurrently. - Proficient in CAD design, engineering drawing creation, and DFM, preferably using SolidWorks, with an emphasis on design for manufacturability and system integration. - Proficient with Microsoft Office Suite and MS Project, with experience in reporting and tracking project metrics. 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. - 7+ years of experience in the Medical device industry, particularly in Orthopedic device. Travel Requirements - Up to 10%. - Willing to consider remote position for candidates for exceptional experience and qualifications.