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Manager, Development Engineering

Company: NuVasive
Location: San Diego
Posted on: August 3, 2020

Job Description:

Job Description NuVasive is seeking an experienced Mechanical or Biomedical Engineer for our Mechanical Systems Integration team. As a Development Manager within our team, you will be accountable for the commercialization of medical devices with enhanced features that allow integration with our robotics enabling technology platform to treat spinal pathologies in accordance with US and international regulations. You will be responsible for the development of innovative mechanical solutions to meet patient and surgeon needs from concept to commercialization. This requires leading cross-functional teams, including marketing, purchasing, regulatory, quality, research and testing, manufacturing, etc, to manage the product development process, project timeline, and deliverables to ensure designs are safe and effective for clinical use as well as directly managing and developing mechanical engineers on the team. Essential Responsibilities - Manage a team of mechanical engineers and related projects to ensure on-time and on-budget commercialization of medical devices. - Participate in and guide project planning, design and phase reviews, mechanical design, technical assessments, and design control documentation. - Mentor a team of mechanical engineers to elevate overall performance and guide professional development. - Work collaboratively with surgeon design and marketing teams to identify unmet clinical needs and distill them into product requirements. - Create and interpret advanced mechanical designs using CAD software suitable for subtractive, additive, sheet metal, and injection molding manufacturing methods while applying DFX principles - Guide, review, and approve documentation relevant to design control and other applicable internal and regulatory requirements. - Review and approve test plans to effectively characterize product performance and establish sufficient design verification and validation test requirements. - Review and approve engineering specifications with dimensions and tolerances appropriate for performance and functional requirements - Review and approve technical assessments of mechanical design (e.g. FEA, tolerance analysis, testing, etc.) - Coordinate with suppliers and procurement teams to manage the production and commercialization process. - Ensure compliance with NuVasive's Quality Management System and applicable US and OUS regulations and standards. - Lead or support cadaver labs during surgeon design team evaluations and surgeon education events, including cadaver setup, running a fluoroscopy machine, clean-up, etc. Basic Qualifications - Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline - Typically requires a minimum of 10 years of related experience in a technical field - Proficiency with CAD software (Pro/E, Creo, or SolidWorks), and Microsoft Office suite - Strong communication skills (verbal & written) including ability to positively influence all levels of internal cross-functional teams, suppliers, surgeons, and sales teams - Expertise in use of project planning tools such as Microsoft Project - Ability to work independently, exercise sound judgment, set direction, manage diverse and conflicting priorities in an effective manner, and meet deadlines with minimal guidance from leadership. - Ability to read and interpret documents such as drawings, safety rules, company policy and procedure manuals - Proficiency in applying concepts of algebra, geometry, trigonometry, calculus, geometric tolerances, and tolerance analysis in addition to ability to solve and interpret problems, collect data, establish facts, and draw valid conclusions - Proven experience interpreting an extensive variety of technical specifications in mathematical or diagram form and managing several abstract and/or concrete variables - Ability to efficiently drive the product development process with cross-functional teams (Supply Chain, Marketing, Quality, Regulatory, Manufacturing, etc.) Preferred Qualifications - Experience with complex mechanical designs preferably in the medical device industry, and ideally in spine - Demonstrated understanding of ISO 13485 and Code of Federal Regulations (CFR) 21 Part 820.30 Design Controls, or equivalent understanding working in a regulated industry

Keywords: NuVasive, San Diego , Manager, Development Engineering, Engineering , San Diego, California

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