Medical Device Product Development Engineer - Spine Job at Expanding Innovations, Mountain View, CA

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  • Expanding Innovations
  • Mountain View, CA

Job Description

About Expanding Innovations

At Expanding Innovations, Inc. (EI), we’re redefining what’s possible in spinal fusion. As a fast-growing leader in non-screw-based expandable cage technologies, we’re committed to solving the most complex clinical challenges faced by today’s spine surgeons—ultimately improving patient outcomes through innovation.

We’re looking for a driven and experienced R&D Engineer to join our collaborative, fast-paced team and help shape the future of spinal device technology.

Position Overview

This on-site role is ideal for an engineer who thrives on innovation, cross-functional collaboration, and seeing ideas through from concept to commercialization. You’ll lead one or more product development projects while contributing to a broader portfolio of initiatives across the R&D team.

Key Responsibilities

Project Leadership

  • 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.

Design & Development

  • 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.).

Risk & Compliance

  • 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.

Innovation & IP

  • Contribute to a culture of innovation by generating new ideas, patents, and intellectual property.
  • Stay current on industry trends, competitive technologies, and emerging materials.

Qualifications

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.

Salary Range : Expanding Innovations, Inc. (EI) complies with all state and federal wage and hour laws. Exact compensation may vary based on candidate’s qualifications, experience, and exact location. $110,000 to $145,000 Full-Time Annual Salary, with annual bonus opportunities and stock incentives.

Why Join Us?

  • Be part of a mission-driven team transforming spinal surgery.
  • Work on cutting-edge technologies with real clinical impact.
  • Grow your career in a dynamic, innovation-focused environment.

Job Tags

Full time, Work experience placement,

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