Job Summary and Primary Responsibilities
Develops and brings innovative mechanical solutions to meet patient and surgeon needs from concept to commercialization for Japan. Works in cross-functional teams from within and outside of US, including set planning, portfolio management, 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. Designs, develops, and assesses new invasive and noninvasive medical device products (implants and instrument systems) for use in complex spinal surgeries in Japan. Assist in improving international processes for defining project scope, planning of launch timing, and resourcing of project team. Conducts feasibility studies of the design to determine ability to function as intended. Maintains detailed documentation throughout all phases of research and development.
- Examines test reports, test materials, and acceptance criteria of previous or on-going submission materials and design control documentation to befit PMDA submission
- Attend PMDA consultation meetings, virtually or in-person, as well as perform worst case justification and testing necessary for regulatory approval in Japan
- Assists and reviews PMDA consultation and submission documents, and work with Japan Regulatory team to define strategy for PMDA submission
- Communicate as a liaison between corporate and Japan NuVasive teams to convey project and process risks, timeline, and launch plans
- Creates and supports the development of prototypes and processes using in-house or external resources
- Leverages CAD software or in-house rapid prototyping equipment to design medical devices and instruments suitable for traditional, novel, and additive manufacturing methods
- Specifies engineering drawings, including assignment of dimensions and tolerances to designs
- 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
- Adheres to project delivery schedules and perform duties in compliance with applicable FDA and Japan regulations as well as standards including, but not limited to, ISO 13485
- Performs other duties such as sustaining engineering as assigned
Required Skills / Capabilities
- Strong preference in business proficiency in both English and Japanese
- Ability to translate requirements into functional mechanical solutions
- Experience with the CAD development environment, component data sheets, and mechanical test methods and equipment
- Strong ability to read and interpret documents such as drawings, safety rules, company policy and procedure manuals
- Understanding of manufacturing processes and design for manufacturing
- Proficiency with Microsoft Office with a strong ability to write business reports and correspondence
- Perform duties in compliance with applicable FDA and Japan regulations as well as standards including, but not limited to, ISO 13485
Education and Experience
- Typically requires a Bachelor's degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience
- Bachelor's or advanced degree in Mechanical Engineering, Biomedical Engineering, or related technical discipline
- Experience in implementing and analyzing mechanical design solutions including ability to perform mechanical design calculations
- Previous international medical device experience preferred
Travel and/or Physical Requirements
- Travel up to 20-25%, including international travel to Japan
For roles 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 .
About NuVasive 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 .