NuVasive is seeking an experienced Electrical Engineering Manager for our Electro-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 navigation enabling technology platform to treat spinal pathologies in accordance with US and international regulations. You will be responsible for the development of innovative electrical solutions to meet patient and surgeon needs from concept to commercialization to sustaining. 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 electrical engineers and technicians on the team.
- Manage a team of electrical engineers and technicians on projects to ensure on-time and on-budget commercialization of medical devices.
- Participate in and guide project planning, design and phase reviews, electrical design, technical assessments, and design control documentation.
- Mentor a team of electrical 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.
- Translate product requirements into circuitry and systems designs.
- Have knowledge in mixed analog/digital design including amplifiers, FPGAs, and embedded microcontrollers.
- Develop specifications of components, circuits, systems and is comprehensive in overall system integration.
- Be familiar with foundational mechanical engineering manufacturing processes (sheet metal, plastic, machined components) to enable effective and efficient design practices with cross-functional teams.
- 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 electrical design (e.g. schematics, board layouts, simulations, de-rating, testing, etc.).
- Coordinate with suppliers and procurement teams to manage the production and commercialization process. Should be familiar with DFM/DFMA principles.
- Have demonstrated experience with design for EMI/EMC, and Electrical Safety with IEC 60601 considerations.
- Implement Risk Management principles per ISO 14971.
- Develop medical devices with product reliability and longevity considerations.
- 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.
Required Skills / Capabilities
- Proficiency with CAD software (Altium preferred), and Microsoft Office suite.
- Knowledge of board layout activities which apply industry best practices.
- 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 or similar.
- 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.
- Ability to efficiently drive the product development process with cross-functional teams (Supply Chain, Marketing, Quality, Regulatory, Manufacturing, etc.).
- 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
Education and Experience
- BSEE/ BSEET or equivalent experience.
- Minimum 8 years related experience.
- Proven experience interpreting an extensive variety of technical specifications in mathematical or diagram form and managing several abstract and/or concrete variables.
- Previous people leadership experience preferred
Experience with complex electro-mechanical designs preferably in the medical device industry, and ideally in spine preferred
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, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company's portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With more than $1 billion in revenues, NuVasive has approximately 2,600 employees and operates in more than 50 countries serving surgeons, hospitals and patients.