Job Summary and Primary Responsibilities
Responsible for managing a group of mechanical engineers to drive the design of electromechanical medical devices to treat spinal pathologies in accordance with US and international regulations. You will lead the design and development of innovative solutions to meet patient and surgeon needs from concept to commercialization. This requires collaboration with cross-functional teams to manage the product development process, mechanical timeline, and deliverables to ensure safe and effective designs for clinical use.
- Manages, mentors, and guides a team of engineers to ensure on-time and on-budget commercialization of capital equipment and medical devices.
- Participates in and guides project planning, design, and phase reviews, mechanical design, technical assessments, and design control documentation
- Guides mechanical engineers, support individual development plans, and fosters a growth and development mentality.
- Instills CAD best practices for complex assemblies; creates and interprets advanced mechanical designs for thermoforming, cast metal, plastic injection molding, machined components, and cabling.
- Mentors engineers on DFX and DFM/A principles
- Guides, reviews, and approves documentation relevant to design control, test plans (verification and validation), and other applicable internal and regulatory requirements
- Reviews and approves engineering specifications with dimensions and tolerances appropriate for performance and functional requirements as well as technical assessments of mechanical design (e.g., FEA, tolerance analysis, testing, etc.)
- Coordinates with suppliers, procurement teams, and design transfer teams to manage the production and commercialization process
- Leads or supports cadaver labs during surgeon design team evaluations and surgeon education events, including cadaver setup, running a fluoroscopy machine, clean-up, etc.
- Performs other duties as assigned
Required Skills / Capabilities
- Proven ability to drive the product development process within deadline and budget
- Demonstrated expertise with CAD software (Pro/E, Creo, or SolidWorks)
- Expertise in DFM/DFA principles
- Demonstrated knowledge and experience with IEC 60601 preferred
- Expertise in the use of project planning tools (SmartSheets, MS Project, PPM Pro/Project Place)
- Demonstrated ability to interpret an extensive variety of technical specifications in mathematical or diagram form and managing several abstract and/or concrete variables
- 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 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a Ph.D. with 3 years' experience; or equivalent experience
- Previous experience leading and coaching a high performing team
- Experience in medical device industry, with complex electromechanical design (spine or orthopedics) and/or emerging technologies preferred
Travel and/or Physical Requirements
Up to 10%
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 .