Expanding Innovations · 2 months ago
Medical Device Product Development Engineer - Spine
Mountain View, CA
Full-time
Onsite
Senior Level
$110K/yr - $145K/yr
5+ years expExpanding Innovations, Inc. (EI) is a fast-growing leader in non-screw-based expandable cage technologies focused on spinal fusion. They are seeking a driven R&D Engineer to lead product development projects and collaborate with cross-functional teams to innovate and improve spinal device technology.
MedicalMedical Device
No H1B
Responsibilities
Lead one or more product development projects from concept through launch
Collaborate with cross-functional teams (Product Management, Regulatory, Quality, Manufacturing) to meet project milestones on time and within budget
Maintain clear project plans and Design History Files (DHF) in compliance with FDA and ISO 13485 standards
Drive the technical design process, including prototyping, testing, and validation
Apply engineering principles to optimize product performance, usability, and manufacturability
Conduct geometric tolerancing analysis and design optimization to enhance the end-user experience
Participate in and lead product testing (feasibility, ASTM, validation, etc.)
Develop and manage risk documentation (DFMEA, PFMEA, UFMEA) in collaboration with the team
Ensure adherence to design controls and regulatory requirements throughout the development lifecycle
Contribute to a culture of innovation by generating new ideas, patents, and intellectual property
Stay current on industry trends, competitive technologies, and emerging materials
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field (Master's or Ph.D. preferred)
5+ years of mechanical design experience in the medical device industry
Proven track record of leading complex product development projects
Deep understanding of spinal anatomy, biomechanics, and surgical techniques
Proficiency in CAD (e.g., SolidWorks), FEA, and other engineering tools
Strong knowledge of FDA regulations, ISO 13485, and ASTM testing standards
Excellent communication skills—able to convey complex technical concepts to diverse audiences
Strong interpersonal skills and a collaborative mindset
Authorized to work in the U.S. (Visa sponsorship is not available for this role)
Preferred
A strong preference for work experience in the spine surgical device space, most notably interbody fusion procedures
Experience with expandable interbody fusion devices
Expertise in GD&T, 1D tolerance analysis, and 3D modeling/analysis
Familiarity with sterile packaging and cleanroom manufacturing
Knowledge of cost-of-goods (COG) optimization through design for manufacturability
Hands-on experience with manufacturing methods such as machining, injection molding, sheet metal forming, and thermoforming
Benefits
Annual bonus opportunities
Stock incentives
Company
Expanding Innovations
Expanding Innovations to develop and commercialize next-generation technology to improve patient outcomes.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Ron Sacher
Executive Chairman, Co-Founder, Board Member
Recent News
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