Manager, R&D Test Lab

Carlsmed•Carlsbad, CA

About The Position

Carlsmed’s mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The Manager, R&D Test Lab supports the Product Development team in developing implants, instruments, and complementary surgical planning and quality production systems that integrate with the company’s universal platform. This role leads the R&D mechanical testing laboratory supporting development and verification of spinal implants, instruments, and associated technologies. It owns lab capability, equipment, capacity, test-method quality, scheduling, and technical execution, while partnering with R&D engineering, Quality, Regulatory, and Operations. The role requires autonomy, teamwork, self-motivation, and commitment to improving patient lives.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Biomechanical Engineering, or a related field.
7–10 years of relevant engineering or testing experience.
Experience collaborating with junior and senior engineers and providing technical guidance and support.
Experience operating electromechanical or servo-hydraulic test systems, such as Instron or MTS, and working with load cells, fatigue testing, fixture design, and statistics/data analysis.
Extensive familiarity with standards and test approaches for interbody devices, spinal constructs, fixation systems, screws, rods, plates, and instruments.
Excellent verbal and written communication skills, including creating presentations and delivering them to senior management.
Strong ability to write and review technical memos, protocols, and reports.
Comprehensive understanding of product risk.
Thorough, detail-oriented approach and ability to execute complex technical work without errors or rework.
Willingness to take on multiple responsibilities to support Carlsmed’s mission.
Autonomous, self-motivated approach and drive to build a service department supporting cross-functional teams.

Nice To Haves

A master’s degree may supplement years of experience, depending on focus.
Experience with spine or orthopedics is highly desired.
Experience with motion-preservation, corpectomy, and other unique spinal constructs.

Responsibilities

Establish and lead day-to-day mechanical testing laboratory and test-frame operations, including capacity planning, prioritization, scheduling, maintenance, calibration coordination, and equipment uptime.
Provide technical leadership for static, fatigue, torsion, compression, bending, pullout, subsidence, construct, and instrument testing according to applicable ASTM standards and the product portfolio.
Oversee development, qualification, and execution of mechanical test methods, fixtures, protocols, and reports; support formal design verification and validation under the company’s QMS and applicable regulatory requirements.
Coordinate cadaveric and animal studies with external research laboratories; develop study protocols with engineers and scientists and manage external testing partnerships, study execution, and technical reporting.
Maintain awareness of applicable ASTM/ISO standards and FDA expectations relevant to spinal implants and instrumentation, and provide guidance for technically sound, repeatable, traceable, and appropriately documented testing.
Partner with engineers to translate design questions and product requirements into meaningful mechanical experiments.
Lead or partner with engineers to investigate complaints or field issues, production issues, anomalous results, equipment issues, test failures, and method variability.
Improve fixtures, automation, data acquisition and analysis, test throughput, laboratory workflows, and documentation.
Partner strategically to establish equipment and capability roadmaps based on the R&D and business pipeline.
Own or contribute to lab CAPEX planning and equipment selection.
Establish lab KPIs for utilization, turnaround time, uptime, on-time completion, OPEX savings, and capacity, and communicate them to leadership.
May manage and develop test engineers, technicians, and/or lab specialists.
May coordinate outside laboratory testing and equipment manufacturers to complement in-house testing.
May require flexible scheduling to align with testing demands.