Position Summary

Seeking an experienced engineer to lead the design, development, and customization of spinal implant instruments. Ideal candidates have expertise in spinal instrumentation, direct collaboration experience with U.S. spine surgeons, and a background in major spinal implant companies. This role involves full product lifecycle development, regulatory compliance, cross-functional teamwork, and close integration with implant design teams.

Key Responsibilities

 Lead product development from concept to commercialization, ensuring compliance with FDA and ISO design control standards.

 Design full instrument systems supporting lumbar (TLIF/PLIF/LLIF/ALIF) and cervical (ACDF) interbody fusion cages, including trials, inserters, distractors, reduction tools, and MIS-compatible workflows.

 Collaborate closely with U.S. spine surgeons and KOLs to collect clinical feedback and customize instruments based on surgical workflow needs.

 Participate in cadaver labs and OR observations to refine usability, ergonomics, workflow, and surgeon handling of instruments.

 Work closely with implant design teams to ensure seamless instrument–implant interface and system-level performance.

 Perform CAD design and modeling, integrating biomechanics and DFM principles.

 Manage project timelines, risks, and cross-functional communication across engineering, quality, regulatory, and manufacturing teams.

 Conduct testing, FEA, mechanical evaluation, and usability assessments as needed for verification and validation.

 Develop and maintain design documentation including DHF, specifications, technical drawings, and risk management files.

 Support regulatory submissions (e.g., 510(k)) and address post-market engineering issues.

Required Qualifications

 Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.

 5–7+ years of medical device development experience, with strong focus on spinal or orthopedic surgical instruments.

 Direct experience collaborating with U.S. spine surgeons on custom instruments and system optimization.

 Proficiency in CAD tools, GD&T, and tolerance stack analysis.

 Knowledge of instrument materials, metals, coatings, finishing processes, and sterilization/cleaning standards.

 Strong understanding of design controls, usability engineering, risk management, and 510(k) regulatory pathways.

 Excellent problem-solving, project management, and communication skills. Preferred Qualifications

 Experience working with major spinal companies (e.g., Medtronic, Stryker, Zimmer Biomet, Globus).

 Successful track record developing spinal instrument systems integrated with interbody implants.

Job Overview

This role focuses on commercializing advanced 3D-printed spinal interbody fusion cages—including lumbar (TLIF/PLIF) and cervical ACDF cages—in the U.S. market. Ideal candidates have strong prior spine sales experience and established surgeon or distributor relationships. You will educate spine surgeons on the clinical value of stiffness-matching lattice implants, support ACDF and lumbar fusion procedures, and drive adoption through high-autonomy sales execution. This role offers significant commission upside for high performers in an early-stage growth environment.

Core Responsibilities

 Execute U.S. regional sales plans for lumbar and cervical (ACDF) 3D-printed interbody fusion cages, achieving revenue and surgeon adoption targets.

 Develop deep relationships with spine surgeons, providing in-OR case support for both ACDF and lumbar fusion procedures.

 Expand and manage local distributor networks; provide product training and sales enablement related to ACDF and lumbar cage systems.

 Identify, target, and convert key accounts across hospitals, ASCs, IDNs, and other spine care facilities.

 Communicate product advantages—including stiffness matching, porosity-driven bone ingrowth, and 3D-printed structural performance—based on surgeon needs and clinical scenarios.

 Participate in regional and national academic conferences, cadaver labs, and clinical training events to increase product visibility.

 Track regional competitive dynamics (PEEK, titanium, 3D-printed offerings) and provide structured insights to the commercial team.

 Coordinate order fulfillment, contracting, and after-sales service to ensure high levels of customer satisfaction.

 Prepare sales reports, forecasts, and account plans on time.

Qualifications

 Bachelor’s degree preferred; life sciences, biomedical engineering, or related disciplines a plus.

 Minimum 2–3 years of spine implant sales experience (required).

 Experience selling ACDF cervical cages, cervical plating, or other anterior cervical systems strongly preferred.

 Experience selling lumbar cages (TLIF/PLIF/LLIF/ALIF) also preferred.

 Existing relationships with U.S. spine surgeons or local spine distributors is a major advantage.

 Comfortable providing OR support for ACDF and lumbar fusion and educating surgeons on implant selection.

 Strong hunter mentality—proactively opens new accounts, drives evaluations, and pushes conversions.

 Able to operate autonomously in a startup environment with minimal supervision.

 Strong communication, technical learning ability, and customer engagement skills.

 Knowledge of FDA regulations and experience with 3D-printed devices is a plus but not required.