Expanding Innovations Inc.
Principal R&D Engineer
Expanding Innovations Inc., Mountain View, California, us, 94039
Job Title: Principal R&D Engineer – Spinal Devices
Company : Expanding Innovations, Inc.Location : Remote, Hybrid or On-Site (Mountain View, CA)About Expanding Innovations:
Expanding Innovations, Inc. (EI) is an emerging technology leader in the expandable interbody cage sector of the Spine Industry. EI is committed to facilitating better patient care by solving the most challenging clinical problems faced by today’s spine surgeons. We are seeking a highly motivated & skilled Principal R&D Engineer to join our dynamic team.Position Overview:
The successful candidate will play a pivotal role in advancing our portfolio of spinal devices, with a particular emphasis on expandable interbody devices. As a Principal R&D Engineer, you will lead one or more development projects as an individual contributor and mentor to younger engineers. Your expertise in engineering and innovative design will contribute to the strategic vision of the company.Responsibilities:
Own one or more product development projects, from conceptualization to commercialization. Lead cross-functional teams to ensure project milestones are met on time and within budget.R&D Expertise:
Leverage extensive R&D experience in the spinal surgery space to drive the development of innovative and clinically designed systems and devices.Create and maintain project plans and FDA compliant Design History Files (DHF) for each project.Stay abreast of industry trends, competitor products, and emerging technologies.Technical Design and Analysis:
Lead the technical aspects of product development, including design, prototyping, testing, and validation.Apply engineering principles to solve complex problems and ensure product performance meets regulatory and quality standards.Perform geometric tolerancing analysis and design optimization to improve end user experience.Complete and participate in necessary product testing (feasibility, ASTM, validations, etc).Work closely with internal teams, including product management, regulatory affairs, quality, and manufacturing, to ensure seamless collaboration throughout the product development lifecycle.Regulatory Compliance:
Stay informed about regulatory requirements and standards related to spinal devices. Collaborate with the regulatory affairs team to ensure products meet all necessary regulatory requirements.Foster a culture of innovation within the R&D team. Encourage and contribute to the generation of new ideas, patents, and intellectual property.Provide technical guidance and mentorship to junior engineers.Qualifications:
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field. Advanced degree (Master’s or Ph.D.) preferred.8+ years of relevant mechanical design experience in the medical device industry.Significant experience in the development of spine surgical devices with a strong preference for expandable interbody experience.Proficient in CAD software (e.g., SolidWorks), finite element analysis, and other engineering tools.Strong understanding of FDA regulations, ISO 13485, and other regulatory requirements for medical devices.ASTM Testing Experience.Excellent written and verbal communication skills.Strong interpersonal skills and the ability to collaborate effectively with colleagues at all levels.Comfortable working in a fast-paced, dynamic environment.US-Based Applicants Only. This position is not eligible for Visa Sponsorship.Preferred Skills:
Wide application of drafting practices, GD&T, 1D tolerance analysis and 3D analysis.Experience working with sterile packaging in medical devices.Familiarity with manufacturing methods: Sheetmetal forming, injection molding, machining, thermoforming of plastics, etc.Expanding Innovations, Inc. (EI) complies with all state and federal wage and hour laws. Exact compensation may vary based on candidate’s qualifications, experience, and location. $130,000 to $175,000 Full-Time Annual Salary.
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Company : Expanding Innovations, Inc.Location : Remote, Hybrid or On-Site (Mountain View, CA)About Expanding Innovations:
Expanding Innovations, Inc. (EI) is an emerging technology leader in the expandable interbody cage sector of the Spine Industry. EI is committed to facilitating better patient care by solving the most challenging clinical problems faced by today’s spine surgeons. We are seeking a highly motivated & skilled Principal R&D Engineer to join our dynamic team.Position Overview:
The successful candidate will play a pivotal role in advancing our portfolio of spinal devices, with a particular emphasis on expandable interbody devices. As a Principal R&D Engineer, you will lead one or more development projects as an individual contributor and mentor to younger engineers. Your expertise in engineering and innovative design will contribute to the strategic vision of the company.Responsibilities:
Own one or more product development projects, from conceptualization to commercialization. Lead cross-functional teams to ensure project milestones are met on time and within budget.R&D Expertise:
Leverage extensive R&D experience in the spinal surgery space to drive the development of innovative and clinically designed systems and devices.Create and maintain project plans and FDA compliant Design History Files (DHF) for each project.Stay abreast of industry trends, competitor products, and emerging technologies.Technical Design and Analysis:
Lead the technical aspects of product development, including design, prototyping, testing, and validation.Apply engineering principles to solve complex problems and ensure product performance meets regulatory and quality standards.Perform geometric tolerancing analysis and design optimization to improve end user experience.Complete and participate in necessary product testing (feasibility, ASTM, validations, etc).Work closely with internal teams, including product management, regulatory affairs, quality, and manufacturing, to ensure seamless collaboration throughout the product development lifecycle.Regulatory Compliance:
Stay informed about regulatory requirements and standards related to spinal devices. Collaborate with the regulatory affairs team to ensure products meet all necessary regulatory requirements.Foster a culture of innovation within the R&D team. Encourage and contribute to the generation of new ideas, patents, and intellectual property.Provide technical guidance and mentorship to junior engineers.Qualifications:
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field. Advanced degree (Master’s or Ph.D.) preferred.8+ years of relevant mechanical design experience in the medical device industry.Significant experience in the development of spine surgical devices with a strong preference for expandable interbody experience.Proficient in CAD software (e.g., SolidWorks), finite element analysis, and other engineering tools.Strong understanding of FDA regulations, ISO 13485, and other regulatory requirements for medical devices.ASTM Testing Experience.Excellent written and verbal communication skills.Strong interpersonal skills and the ability to collaborate effectively with colleagues at all levels.Comfortable working in a fast-paced, dynamic environment.US-Based Applicants Only. This position is not eligible for Visa Sponsorship.Preferred Skills:
Wide application of drafting practices, GD&T, 1D tolerance analysis and 3D analysis.Experience working with sterile packaging in medical devices.Familiarity with manufacturing methods: Sheetmetal forming, injection molding, machining, thermoforming of plastics, etc.Expanding Innovations, Inc. (EI) complies with all state and federal wage and hour laws. Exact compensation may vary based on candidate’s qualifications, experience, and location. $130,000 to $175,000 Full-Time Annual Salary.
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