Job Summary and Primary Responsibilities
At NuVasive, our goal is to change a patient's life every minute of every day. Come join our outcome driven, innovative team that is developing emerging technologies to enable the future of spine surgery through navigation and robotics innovation!
Designs and develops new invasive and noninvasive medical device products (implants and instrument systems) designed for use in complex spinal surgeries that integrate into our robotics technology platforms. Develops innovative mechanical solutions to meet patient and surgeon needs from concept to commercialization. Works in cross-functional teams, including, regulatory, quality, research and testing, manufacturing, etc., to help manage the product development process, project timeline, and deliverables to ensure designs are safe and effective for clinical use. Conducts feasibility studies of the design to determine ability to function as intended. Maintains detailed documentation throughout all phases of research and development.
- Leads projects to on-time and on-budget completion in most areas of the product development process
- Creates advanced mechanical designs using CAD software or in-house rapid prototyping equipment suitable for traditional, novel, and additive manufacturing methods while applying design for manufacturing principles
- Creates engineering specifications with dimensions and tolerances appropriate for performance and functional requirements
- Creates and maintains documentation relevant to design control and other applicable regulatory requirements
- Documents technical assessments of mechanical design (eg FEA, tolerance analysis, testing, etc.)
- Supports manufacturing of viable designs using in-house rapid prototyping equipment or by outsourcing to external suppliers
- Leads or supports cadaver labs during surgeon design team evaluations and surgeon education events, including cadaver setup, running a fluoroscopy machine, clean-up, etc.
- Adheres to project delivery schedules and perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485
- Performs other duties as assigned
Required Skills / Capabilities
- Proficiency with CAD software (Pro/E, Creo, or SolidWorks), and Microsoft Office with a strong ability to write technical reports, business reports, and correspondence
- Proficiency and knowledge 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
- Ability to read and interpret documents such as drawings, safety rules, company policy and procedure manuals
- Understanding of manufacturing processes and design for manufacturing
- Ability to work independently, exercise sound judgment, manage diverse and conflicting priorities in an effective manner, and meet deadlines with guidance from leadership
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485
Education and Experience
- Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience
- Bachelor's or advanced degree in Mechanical Engineering, Biomedical Engineering, or related technical discipline
- Experience with Geometric Dimensioning & Tolerance
- Previous medical device experience; spine or orthopedics preferred.
- Experience with developing complex instruments/mechanisms preferred.
Travel and/or Physical Requirements
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here. NuVasive's EEO policy is available here.
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company's less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company's comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.