Senior/Principal R&D Engineer - Spinal Devices

Expanding Innovations; United States; On-site; USD 130,000 - 175,000; Full time

Job summary

A leading spinal technology company is seeking a Senior/Principal R&D Engineer with over 8 years of experience in the medical device industry. The role involves managing product development for innovative spinal technologies, ensuring regulatory compliance, and collaborating across teams. Ideal candidates will have a Mechanical Engineering background, CAD proficiency, and strong problem-solving skills. This full-time position offers a salary ranging from $130,000 to $175,000 along with bonuses and stock incentives.

Qualifications

• 8+ years of experience in medical device industry.
• Experience in development of spine surgical devices.
• Knowledge of FDA regulations and ISO 13485.

Responsibilities

• Lead product development initiatives from concept through commercialization.
• Manage cross-functional teams to deliver projects on time.
• Ensure compliance with regulatory and quality standards.

Skills

Mechanical design experience

CAD software proficiency

Strong analytical skills

Communication skills

Education

Bachelor’s degree in Mechanical Engineering or related field

Master’s or Ph.D. preferred

Tools

SolidWorks

Finite element analysis

Job description

Senior/Principal R&D Engineer - Spinal Devices

Direct message the job poster from Expanding Innovations

VP of Product & Strategy | Driving Innovation in Spinal Medical Devices | Cross-Functional Leader with 12+ Years in MedTech

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

Expanding Innovations is seeking a highly skilled and driven Senior or Principal R&D Engineer to lead the development of next‑generation spinal technologies. In this pivotal role, you will spearhead major product development initiatives, with a strong focus on innovative expandable interbody devices. As a senior member of our engineering team, you will provide technical leadership, mentor junior engineers, and contribute to shaping the strategic direction of our product portfolio. Your deep industry knowledge, engineering expertise, and creative approach to design will be instrumental in advancing our mission to deliver cutting‑edge solutions that improve patient outcomes.

Responsibilities

• Lead one or more product development initiatives from concept through commercialization, ensuring alignment with strategic goals.
• Manage cross‑functional teams to deliver projects on time and within budget, while maintaining high standards of quality and innovation.

R&D Expertise

• Apply deep expertise in spinal surgery technologies to develop clinically impactful and commercially viable systems and devices.
• Develop and maintain comprehensive project documentation, including FDA‑compliant Design History Files (DHF).
• Monitor industry trends, competitive products, and emerging technologies to inform and enhance development strategies.

Technical Design & Analysis

• Drive the technical execution of product development, including design, prototyping, testing, and validation.
• Utilize advanced engineering principles to solve complex challenges and ensure compliance with regulatory and quality standards.
• Conduct geometric dimensioning and tolerancing (GD&T) analysis and design optimization to enhance usability and performance.
• Lead and participate in product testing activities, including feasibility studies, ASTM testing, and validation protocols.

Cross‑Functional Collaboration

• Partner closely with internal stakeholders—product management, regulatory affairs, quality, and manufacturing—to ensure cohesive execution throughout the product lifecycle.

Regulatory Compliance

• Maintain up‑to‑date knowledge of regulatory standards and requirements for spinal devices.
• Collaborate with the regulatory team to ensure all products meet applicable regulatory and submission requirements.
• Champion a culture of innovation within the R&D team by fostering idea generation and supporting the development of intellectual property, including patents.
• Provide technical leadership and mentorship to junior engineers, sharing best practices and fostering professional growth across the team.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field. Advanced degree (Master’s or Ph.D.) preferred.
• 8+ years of relevant mechanical design experience in the medical device industry. Proven track record of successfully leading and delivering complex projects.
• Significant experience in the development of spine surgical devices with a strong preference for expandable interbody experience. Knowledge of spinal anatomy, biomechanics, and surgical techniques.
• Proficient in CAD software (e.g., SolidWorks), finite element analysis, and other engineering tools. Strong analytical and problem‑solving skills.
• Strong understanding of FDA regulations, ISO 13485, and other regulatory requirements for medical devices.
• ASTM testing experience. Kinematic and stress analysis of mechanical systems.
• Excellent written and verbal communication skills. Ability to effectively communicate complex technical information to both technical and non‑technical stakeholders.
• Strong interpersonal skills and the ability to collaborate effectively with colleagues at all levels.
• Comfortable working in a fast‑paced, dynamic environment. Ability to adapt to changing priorities and thrive in a challenging and innovative atmosphere.

US‑Based Applicants Only. This position is not eligible for Visa Sponsorship.

Preferred Skills

• Wide application of drafting practices, GD&T, 1D tolerance analysis and 3D analysis.
• Experience working with sterile packaging in medical devices.
• Demonstrated ability to proactively consider COG consolidation through design manufacturability.
• Familiarity with manufacturing methods: Sheetmetal forming, injection molding, machining, thermoforming of plastics, etc.

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. $130,000 to $175,000 Full‑Time Annual Salary, with annual bonus opportunities and stock incentives.

Seniority level: Mid‑Senior level

Employment type: Full‑time

Job function: Engineering and Information Technology

Industries: Medical Equipment Manufacturing